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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/NCT02247479
Registration number
NCT02247479
Ethics application status
Date submitted
15/07/2014
Date registered
25/09/2014
Date last updated
26/06/2019
Titles & IDs
Public title
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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Scientific title
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
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Secondary ID [1]
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2014-000107-27
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Secondary ID [2]
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GX29176
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Universal Trial Number (UTN)
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Trial acronym
CHROMA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lampalizumab
Other interventions - Sham
Experimental: Lampalizumab Once in Every 4 Weeks (Q4W) - Participants will receive 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Experimental: Lampalizumab Once in Every 6 Weeks (Q6W) - Participants will receive 10 mg dose of lampalizumab administered by intravitreal injections for approximately 96 weeks.
Sham Comparator: Sham Comparator - Participants will receive sham comparator Q4W or Q6W for 96 weeks.
Treatment: Drugs: Lampalizumab
Participants will receive 10 mg dose of lampalizumab administered intravitreally.
Other interventions: Sham
A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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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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Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48
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Assessment method [1]
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The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
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Timepoint [1]
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Baseline, Week 48
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Primary outcome [2]
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Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48
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Assessment method [2]
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For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
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Timepoint [2]
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Baseline, Week 48
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Secondary outcome [1]
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Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48
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Assessment method [1]
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Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.
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Timepoint [1]
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Baseline, Week 48
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Secondary outcome [2]
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Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48
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Assessment method [2]
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Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [2]
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Baseline, Week 48
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Secondary outcome [3]
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Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48
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Assessment method [3]
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BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [3]
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Baseline, Week 48
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Secondary outcome [4]
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Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48
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Assessment method [4]
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Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48
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Assessment method [5]
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The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [5]
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Baseline, Week 48
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Secondary outcome [6]
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Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48
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Assessment method [6]
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Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [6]
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Week 48
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Secondary outcome [7]
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Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48
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Assessment method [7]
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MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [7]
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Baseline, Week 48
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Secondary outcome [8]
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Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48
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Assessment method [8]
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MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [8]
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Baseline, Week 48
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Secondary outcome [9]
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Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48
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Assessment method [9]
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NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision-specific social functioning, vision-specific mental health, vision-specific role difficulties, vision-specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [9]
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Baseline, Week 48
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Secondary outcome [10]
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Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48
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Assessment method [10]
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NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [10]
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Baseline, Week 48
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Secondary outcome [11]
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Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48
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Assessment method [11]
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NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [11]
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Baseline, Week 48
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Secondary outcome [12]
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Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48
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Assessment method [12]
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The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.
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Timepoint [12]
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Baseline, Week 48
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Eligibility
Key inclusion criteria
- Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular
Degeneration (AMD) with no evidence of prior or active choroidal neovascularization
(CNV) in both eyes
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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 Study Eye
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for
AMD
- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
occlusion, and proliferative diabetic retinopathy
- Previous intravitreal drug delivery (intravitreal corticosteroid injection,
anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular
Both Eyes
- GA in either eye due to causes other than AMD
- Previous treatment with eculizumab, lampalizumab and/or fenretinide
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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 administering 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
Terminated
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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
18/09/2014
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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
29/01/2018
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Sample size
Target
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Accrual to date
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Final
906
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Eyeclinic Albury Wodonga - Albury
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Recruitment hospital [2]
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Marsden Eye Research Centre - Parramatta
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Recruitment hospital [3]
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Save Sight Institute - Sydney
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Recruitment hospital [4]
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Sydney West Retina - Westmead
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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2150 - Parramatta
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Recruitment postcode(s) [3]
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2000 - Sydney
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Recruitment postcode(s) [4]
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2145 - Westmead
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Recruitment outside Australia
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Alabama
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Florida
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Georgia
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Lima
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Zilina
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Alicante
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Valencia
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AYR
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United Kingdom
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State/province [82]
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Ethics approval
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Summary
Brief summary
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled
study evaluating the efficacy and safety of lampalizumab administered by intravitreal
injections in participants with geographic atrophy (GA) secondary to age-related macular
degeneration (AMD).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02247479
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02247479
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