Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

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

Keywords

Proliferative Diabetic Retinopathy proliferative diabetic retinophathy, retinal neovascularization, anti-VEGF, brolucizumab, intravitreal injection, panretinal photocoagulation Retinal Diseases Diabetic Retinopathy Brolucizumab 6 mg Panretinal photocoagulation laser

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Signed informed consent must be obtained prior to participation
  2. Able to complete adequate fundus photographs and retinal images
  3. Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
  4. DM treatment stable for at least 3 months
  5. PDR diagnosis with no previous PRP treatment in the study eye

You CAN'T join if...

  1. Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
  2. Presence of diabetic macular edema in the study eye Active infection or inflammation in the study eye
  3. Uncontrolled glaucoma (IOP greater than 25 mmHg)
  4. Intravitreal anti-VEGF treatment within 6 months
  5. Treatment with intraocular corticosteroids
  6. End stage renal disease requiring dialysis or kidney transplant
  7. Uncontrolled blood pressure
  8. Systemic anti-VEGF therapy at any time Other protocol-defined inclusion/exclusion criteria may apply -

Locations

  • Novartis Investigative Site accepting new patients
    Sacramento California 95817 United States
  • Novartis Investigative Site accepting new patients
    Rancho Cordova California 95670 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
Links
Sign up for this study
ID
NCT04278417
Phase
Phase 3
Study Type
Interventional
Last Updated