CompletedPhase 3

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

United States, Argentina, Australia689 participantsStarted 2020-11-19

Plain-language 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 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 participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye

Timeframe: Baseline, Week 54

Trial details

NCT IDNCT04278417

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-30

Results submitted2024-06-24

View on ClinicalTrials.gov More Proliferative Diabetic Retinopathy trials