Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
EXCLUSION CRITERIA
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Proliferative Diabetic Retinopathy
Age (in years)
18+
Phase
Phase 3
Participants needed
694
Est. Completion Date
Aug 20, 2024
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT04278417
Study number
CRTH258D2301
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