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

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

ClinicalTrials.gov Identifier: NCT04278417

Novartis Reference Number: CRTH258D2301

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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. 

Study Description

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.

Condition 
Proliferative Diabetic Retinopathy
Phase 
Phase 3
Overall status 
Not yet recruiting
Enrollment count 
706 participants
Start date 
Sep 01, 2020
Completion date 
Apr 02, 2024
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
Brolucizumab 6 mg
3 x q6w loading injections, followed by q12w maintenance through Week 90
Procedure
Panretinal photocoagulation laser
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Eligibility 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:

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 -

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]