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NCT04278417 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
A Phase 3 study of Proliferative Diabetic Retinopathy, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 689
- Enrollment target
- 20
- Study locations
NCT04278417: Completed Phase 3 study of Proliferative Diabetic Retinopathy, sponsored by Novartis Pharmaceuticals.
NCT04278417 is a Phase 3 study of Proliferative Diabetic Retinopathy that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 689 participants, above the 79-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (772% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04278417, a Phase 3 study of Proliferative Diabetic Retinopathy, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 689 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of \>= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of
Conditions Studied
Interventions
- BIOLOGICAL Brolucizumab 6 mg
- PROCEDURE Panretinal photocoagulation laser
Study Locations (20)
Florida
- Advanced Research LLC - Deerfield Beach
- Rand Eye Institute - Deerfield Beach
- Pinnacle Research Institute - Fort Lauderdale
- National Ophthalmic Research Institute - Fort Myers
- Florida Retina Institute - Jacksonville
- Blue Oc Clin Res at Palm Bch Eye Ct - Lakeland
- MedEye Associates - Miami
- Florida Retina Institute - Orlando
- Eye Center of North Florida - Panama City
- Fort Lauderdale Eye Institute - Plantation
California
- Retina- Vitreous Assoc Medical Group - Beverly Hills
- Retina Consultants of Orange County - Fullerton
- Salehi Retina Institute - Huntington Beach
- Retina Consultants of Southern California - Redlands
- Premiere Practice Management LLC - Torrance
- Lundquist Inst BioMed at Harbor - Torrance
- Miramar Eye Specialists - Ventura
Arizona
- Retina Associates SW - Tucson
Illinois
- Retina Associates - Elmhurst
Indiana
- Midwest Eye Institute - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 689 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2024-08-19 |
| Phase | Phase 3 |
What the finished NCT04278417 record still lists
NCT04278417 is an interventional study that assigns participants to a tested intervention. The registered 689 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (772% higher).
The record links to 1 condition, with Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which Brolucizumab 6 mg is the first listed.
NCT04278417 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04278417 about?
NCT04278417 is a clinical study titled "Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy". 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 chang...
What is the current status of trial NCT04278417?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 689 participants. The study started on 2020-11-19. Estimated completion is 2024-08-19.
What conditions does trial NCT04278417 study?
This clinical trial studies the following conditions: Proliferative Diabetic Retinopathy.
What interventions are being tested in trial NCT04278417?
The interventions under investigation include: Brolucizumab 6 mg (BIOLOGICAL), Panretinal photocoagulation laser (PROCEDURE).
Who is sponsoring clinical trial NCT04278417?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04278417 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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