Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

Completed · Phase 3

Conditions studied: Proliferative Diabetic Retinopathy

In brief

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 evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Key facts

Study ID

NCT04278417

Run by

Novartis Pharmaceuticals

People needed

689

Starts

2020-11-19

Expected to finish

2024-08-19

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Retina- Vitreous Assoc Medical Group — Beverly Hills, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Salehi Retina Institute — Huntington Beach, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• Premiere Practice Management LLC — Torrance, California, United States
• Lundquist Inst BioMed at Harbor — Torrance, California, United States
• Miramar Eye Specialists — Ventura, California, United States
• Advanced Research LLC — Deerfield Beach, Florida, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Pinnacle Research Institute — Fort Lauderdale, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Retina Institute — Jacksonville, Florida, United States
• Blue Oc Clin Res at Palm Bch Eye Ct — Lakeland, Florida, United States
• MedEye Associates — Miami, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Eye Center of North Florida — Panama City, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Associates — Elmhurst, Illinois, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• John-Kenyon American Eye Institute PC — New Albany, Indiana, United States
• Retina Associates PA — Lenexa, Kansas, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• University of Mississippi Med Ctr — Jackson, Mississippi, United States
• Retina Associates Of Cleveland — Cleveland, Ohio, United States
• Retina Associates SW — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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