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
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Proliferative Diabetic Retinopathy
Nov 19, 2020
Jan 10, 2025
18 Years and older (Adult, Older Adult)
Brolucizumab 6 mg
3 x q6w loading injections, followed by q12w maintenance through Week 90
Panretinal photocoagulation laser
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
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
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 -