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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/NCT04278417
Registration number
NCT04278417
Ethics application status
Date submitted
18/02/2020
Date registered
20/02/2020
Date last updated
16/04/2024
Titles & IDs
Public title
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
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Scientific title
A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
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Secondary ID [1]
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CRTH258D2301
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Universal Trial Number (UTN)
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Trial acronym
CONDOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Proliferative Diabetic Retinopathy
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Brolucizumab 6 mg
Treatment: Surgery - Panretinal photocoagulation laser
Experimental: Brolucizumab Arm - Intra-vitreal injection
Active Comparator: Panretinal photocoagulation laser Arm - laser
Other interventions: Brolucizumab 6 mg
3 x q6w loading injections, followed by q12w maintenance through Week 90
Treatment: Surgery: Panretinal photocoagulation laser
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Surgery
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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 BCVA
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Assessment method [1]
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To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54
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Timepoint [1]
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At Week 54
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Secondary outcome [1]
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Proportion of subjects with no PDR at Week 54
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Assessment method [1]
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To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at Week 54
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Timepoint [1]
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At Week 54
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Secondary outcome [2]
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Proportion of subjects with center-involved DME up to Week 54
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Assessment method [2]
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To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to Week 54
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Timepoint [2]
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At Week 54
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Secondary outcome [3]
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Area under the curve in change from Baseline in BCVA up to Week 54 and Week 96
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Assessment method [3]
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To compare the effect of brolucizumab relative to PRP with respect to visual acuity
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Timepoint [3]
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From Baseline in BCVA up to Week 54 and Week 96
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Secondary outcome [4]
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Change from Baseline in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at Week 54 and Week 96
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Assessment method [4]
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To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status
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Timepoint [4]
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From Baseline score to Week 54 and Week 96
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Secondary outcome [5]
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Proportion of subjects with no PDR at Week 96
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Assessment method [5]
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To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status
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Timepoint [5]
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At Week 96
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Secondary outcome [6]
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Proportion of study eyes developing vision-threatening complications associated with diabetic retinopathy up to Week 54 and Week 96
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Assessment method [6]
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To compare the effect of brolucizumab relative to PRP on ocular complications
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Timepoint [6]
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At Week 54 and Week 96
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Secondary outcome [7]
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Proportion of subjects with center-involved DME up to Week 96
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Assessment method [7]
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To compare the effect of brolucizumab relative to PRP on ocular complications
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Timepoint [7]
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At Week 96
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Eligibility
Key inclusion criteria
- Signed informed consent must be obtained prior to participation
- Able to complete adequate fundus photographs and retinal images
- Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at
screening
- DM treatment stable for at least 3 months
- PDR diagnosis with no previous PRP treatment in the study eye
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Minimum age
18
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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
- Concomitant conditions or ocular disorders in the study eye at Screening or Baseline
that could compromise a response to study treatment.
- Presence of diabetic macular edema in the study eye
- Active infection or inflammation in the study eye
- Uncontrolled glaucoma (IOP greater than 25 mmHg)
- Intravitreal anti-VEGF treatment within 6 months
- Treatment with intraocular corticosteroids
- End stage renal disease requiring dialysis or kidney transplant
- Uncontrolled blood pressure
- Systemic anti-VEGF therapy at any time
Other protocol-defined inclusion/exclusion criteria may apply.
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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 assessing the outcomes
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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
Active, not recruiting
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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
19/11/2020
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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
20/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
689
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novartis Investigative Site - Albury
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Novartis Investigative Site - Liverpool
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Novartis Investigative Site - Parramatta
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Novartis Investigative Site - Strathfield
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2640 - Albury
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2170 - Liverpool
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2150 - Parramatta
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Recruitment postcode(s) [4]
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2135 - Strathfield
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Recruitment outside Australia
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to
panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy
(PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with
respect to the change in best corrected visual acuity at Week 54.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04278417
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Trial related presentations / publications
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04278417
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