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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04005352
Registration number
NCT04005352
Ethics application status
Date submitted
1/07/2019
Date registered
2/07/2019
Date last updated
17/05/2024
Titles & IDs
Public title
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
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Scientific title
A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)
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Secondary ID [1]
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2019-000716-28
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Secondary ID [2]
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CRTH258A2303
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Universal Trial Number (UTN)
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Trial acronym
TALON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Age-related Macular Degeneration
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Condition category
Condition code
Eye
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Brolucizumab 6 mg
Other interventions - Aflibercept 2 mg
Experimental: Brolucizumab 6 mg - 3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62.
Active Comparator: Aflibercept 2 mg - 3 x 4-week injections and one 8-week Intra-vitreal injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62
Other interventions: Brolucizumab 6 mg
Intra-vitreal injection
Other interventions: Aflibercept 2 mg
Intra-vitreal injection
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye
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Assessment method [1]
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No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. Intraretinal Fluid (IRF), Subretinal Fluid (SRF), hemorrhage, leakage, etc.).
Treatment interval distribution. Number (%) of subjects at 12/8/4-weeks intervals up to Week 32 for the study eye.
If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks).
If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or =12-week then the floor value of these ranges was used.
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Timepoint [1]
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Up to Week 32
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Primary outcome [2]
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Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye
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Assessment method [2]
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BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Least squares mean estimate - for weeks 28 and 32 combined.
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Timepoint [2]
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Baseline, Week 28 and Week 32
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Secondary outcome [1]
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Distribution of the Last Interval With no Disease Activity up to Week 64 - Study Eye
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Assessment method [1]
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No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.).
Treatment interval distribution. The number of subjects at 16/12/8/4-weeks intervals as the last interval with no disease activity.
If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks).
If the duration of the last interval falls within the following ranges of (4-week, 8-week) or (8-week, 12-week) or (12-weeks, 16-weeks) or =16-week then the floor value of these ranges was used.
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Timepoint [1]
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Up to Week 64
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Secondary outcome [2]
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Distribution of the Maximal Intervals With no Disease Activity up to Week 64 - Study Eye
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Assessment method [2]
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No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.).
Maximal interval distribution. Number of subjects at 16/12/8/4-weeks intervals as the last interval with no disease activity.
If the study treatment is discontinued before Week 16 included, then the treatment interval is 4 weeks; otherwise, the last interval with no disease activity is used (if there was disease activity, the last interval is shortened by 4 weeks, down to a minimum of 4 weeks).
If the duration of the maximal interval falls within the following ranges of [4-weeks, 8-weeks) or [8-weeks, 12-weeks) or [12-weeks, 16-weeks] or =16-weeks then the floor value of these ranges is used.
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Timepoint [2]
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Up to Week 64
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Secondary outcome [3]
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Number of Participants With no Disease Activity - Study Eye
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Assessment method [3]
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Disease activity assessment as determined by visual acuity and assessment of other signs of the disease (e.g. IRF, SRF, hemorrhage, leakage, etc.).
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Timepoint [3]
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Weeks 14 and 16
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Secondary outcome [4]
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Time From Last Loading Injection to First Visit With No Disease Activity (Weeks) - 75th Percentile - Study Eye
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Assessment method [4]
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Intraretinal fluid (IRF) and subretinal fluid (SRF) were assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye).
Please note that this endpoint can be impacted by the optional disease activity assessment visits and the flexible dosing regimen, in addition to the randomized treatment. Hence, the observed treatment effect may be confounded by the study design artifacts.
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Timepoint [4]
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Up to Week 64
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Secondary outcome [5]
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Time-to-first Dry Retina - Time to the First Visit With no Intraretinal Fluid (IRF) or Subretinal Fluid (SRF) - Study Eye
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Assessment method [5]
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Intraretinal fluid (IRF) and subretinal fluid (SRF) were assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye).
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Timepoint [5]
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Up to Week 64
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Secondary outcome [6]
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Average Change From Baseline at Week 60 and Week 64 in Best-corrected Visual Acuity (BCVA) - Study Eye
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Assessment method [6]
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BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
Least squares mean estimate - for weeks 60 and 64 combined.
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Timepoint [6]
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Baseline, Week 60 and Week 64
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Secondary outcome [7]
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Number of Participants With Best-corrected Visual Acuity Improvements of = 15 Letters in BCVA From Baseline or Reached BCVA = 84 Letters up to Week 32/64 Per Treatment Arm - Study Eye
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Assessment method [7]
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BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
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Timepoint [7]
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Baseline, Week 32, and Week 64
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Secondary outcome [8]
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Number of Participants With Best-corrected Visual Acuity = 69 Letters - Study Eye
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Assessment method [8]
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BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
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Timepoint [8]
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Week 32 and Week 64
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Secondary outcome [9]
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Average Change From Baseline in Central Subfield Thickness (CSFT) - Study Eye
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Assessment method [9]
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CSFT was measured by Spectral Domain Optical Coherence Tomography
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Timepoint [9]
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Baseline, Weeks 28 and 32 and at Weeks 60 and 64
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Secondary outcome [10]
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Number of Participants With Presence of Intraretinal Fluid and/or Subretinal Fluid in the Central Subfield - Study Eye
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Assessment method [10]
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Intraretinal Fluid and/or Subretinal Fluid status was measured by Spectral Domain Optical Coherence Tomography (SD-OCT).
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Timepoint [10]
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At Weeks 28, 32, 60 and 64
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Secondary outcome [11]
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Number of Participants With Presence of Sub-Retinal Pigment Epithelium Fluid in the Central Subfield - Study Eye
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Assessment method [11]
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Sub-Retinal Pigment Epithelium fluid status was measured by Spectral Domain Optical Coherence Tomography (SD-OCT).
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Timepoint [11]
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At Weeks 28, 32, 60 and 64
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Secondary outcome [12]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Composite Scores - Study Eye
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Assessment method [12]
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The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [12]
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Baseline, Week 32, and Week 64
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Secondary outcome [13]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - General Vision - Study Eye
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Assessment method [13]
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The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [13]
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Baseline, Week 32, and Week 64
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Secondary outcome [14]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Ocular Pain - Study Eye
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Assessment method [14]
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The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [14]
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Baseline, Week 32, and Week 64
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Secondary outcome [15]
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Change From Baseline n Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Near Activities - Study Eye
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Assessment method [15]
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The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [15]
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Baseline, Week 32, and Week 64
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Secondary outcome [16]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Distance Activities - Study Eye
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Assessment method [16]
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The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [16]
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Baseline, Week 32, and Week 64
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Secondary outcome [17]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Social Functioning - Study Eye
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Assessment method [17]
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The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [17]
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Baseline, Week 32, and Week 64
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Secondary outcome [18]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Mental Health - Study Eye
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Assessment method [18]
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0
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [18]
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Baseline, Week 32, and Week 64
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Secondary outcome [19]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Role Difficulties - Study Eye
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Assessment method [19]
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0
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [19]
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Baseline, Week 32, and Week 64
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Secondary outcome [20]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Dependency - Study Eye
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Assessment method [20]
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0
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning or outcome. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [20]
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Baseline, Week 32, and Week 64
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Secondary outcome [21]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Driving - Study Eye
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Assessment method [21]
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0
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [21]
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Baseline, Week 32, and Week 64
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Secondary outcome [22]
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Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Color Vision - Study Eye
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Assessment method [22]
0
0
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [22]
0
0
Baseline, Week 32, and Week 64
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Secondary outcome [23]
0
0
Change From Baseline in Visual Function Questionnnaire-25 (VFQ-25) - Subscale Score - Peripheral Vision - Study Eye
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Assessment method [23]
0
0
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. Each subscale score has a range of 0 to 100 inclusive and will be calculated from the re-scaled raw data. A composite score is derived based on the average of the 11 subscales.
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Timepoint [23]
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Baseline, Week 32, and Week 64
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Secondary outcome [24]
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Number of Participants With Treatment Emergent Ocular Adverse Events (Greater Than or Equal to 1% in Any Treatment Arm) by Preferred Term for the Study Eye
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Assessment method [24]
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An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject.
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Timepoint [24]
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Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years.
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Secondary outcome [25]
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Number of Participants With Treatment Emergent Non-ocular Adverse Events (Greater Than or Equal to 2% in Any Treatment Arm) - Summary Table
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Assessment method [25]
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An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease) in a subject or clinical investigation subject.
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Timepoint [25]
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Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 483 days, approx. 69 weeks, 1.3 years.
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Eligibility
Key inclusion criteria
- Signed informed consent must be obtained prior to participation in the study
- Male or female patients = 50 years of age at screening who are treatment naive
- Active choroidal neovascularization (CNV) secondary to AMD that affects the central
subfield, including retinal angiomatous proliferation (RAP) with a CNV component,
confirmed by presence of active leakage from CNV seen by fluorescein angiography and
sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal
pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema (study
eye)
- Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the
central subfield, as seen by Spectral Domain Optical Coherence Tomography (SD-OCT)
(study eye)
- Best-corrected visual acuity (BCVA) score between 83 and 38 letters, inclusive, using
Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at
both screening and baseline visit (study eye)
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Ocular conditions/disorders at screening or baseline which could, in the opinion of
the investigator, prevent response to study treatment or may confound interpretation
of study results, compromise visual acuity or require planned medical or surgical
intervention during the first 12-month study period, structural damage of the fovea,
atrophy or fibrosis at the center of the fovea (study eye)
- Any active intraocular or periocular infection or active intraocular inflammation, at
screening or baseline (study eye)
- Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication,
or according to investigator's judgment, at screening or baseline (study eye)
- Ocular treatments: previous treatment with any anti-vascular endothelial growth factor
(VEGF) drugs or investigational drugs, intraocular or periocular steroids, macular
laser photocoagulation, photodynamic therapy, vitreoretinal surgery, intraocular
surgery (study eye)
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Systemic anti-VEGF therapy at any time.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/09/2022
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Sample size
Target
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Accrual to date
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Final
734
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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0
Novartis Investigative Site - Albury
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Recruitment hospital [2]
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Novartis Investigative Site - Hurstville
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Recruitment hospital [3]
0
0
Novartis Investigative Site - Parramatta
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Recruitment hospital [4]
0
0
Novartis Investigative Site - Sydney
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Recruitment hospital [5]
0
0
Novartis Investigative Site - Southport
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Recruitment hospital [6]
0
0
Novartis Investigative Site - Glen Waverley
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Recruitment hospital [7]
0
0
Novartis Investigative Site - Rowville
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Recruitment hospital [8]
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0
Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
0
0
2640 - Albury
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Recruitment postcode(s) [2]
0
0
2220 - Hurstville
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Recruitment postcode(s) [3]
0
0
2150 - Parramatta
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Recruitment postcode(s) [4]
0
0
2000 - Sydney
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Recruitment postcode(s) [5]
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0
4215 - Southport
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Recruitment postcode(s) [6]
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0
3150 - Glen Waverley
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Recruitment postcode(s) [7]
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0
3179 - Rowville
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Recruitment postcode(s) [8]
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0
6009 - Nedlands
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Iowa
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Minnesota
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Country [8]
0
0
United States of America
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State/province [8]
0
0
North Carolina
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Oregon
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Tennessee
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Texas
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Funding & Sponsors
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Novartis Pharmaceuticals
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Summary
Brief summary
This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study
in patients with neovascular age related macular degeneration (nAMD) who have not previously
received anti- vascular endothelial growth factor (VEGF) treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04005352
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04005352
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