Status:
COMPLETED
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Proliferative Diabetic Retinopathy
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This ev...
Detailed Description
Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (P...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2024
Estimated Enrollment :
689 Patients enrolled
Trial Details
Trial ID
NCT04278417
Start Date
November 19 2020
End Date
August 19 2024
Last Update
October 16 2025
Active Locations (120)
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1
Retina Associates SW
Tucson, Arizona, United States, 85704
2
Retina- Vitreous Assoc Medical Group
Beverly Hills, California, United States, 90211
3
Retina Consultants of Orange County
Fullerton, California, United States, 92835
4
Salehi Retina Institute
Huntington Beach, California, United States, 92647