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NCT04265261 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
A Phase 2 study of Diabetic Retinopathy, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 139
- Enrollment target
- 20
- Study locations
NCT04265261: Completed Phase 2 study of Diabetic Retinopathy, sponsored by Hoffmann-La Roche.
NCT04265261 is a Phase 2 study of Diabetic Retinopathy that has completed, run by Hoffmann-La Roche. The registered enrollment target is 139 participants, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04265261, a Phase 2 study of Diabetic Retinopathy, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 139 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.
Primary Outcome
The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RG7774
Study Locations (20)
Florida
- Rand Eye - Deerfield Beach
- Florida Retina Consultants - Lakeland
- Florida Eye Associates - Melbourne
- Medeye Associates - Miami
- Retina Specialty Institute - Pensacola
- Retina Vitreous Assoc of FL - St. Petersburg
California
- Win Retina - Arcadia
- Global Research Management - Glendale
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Arizona
- Arizona Retina and Vitreous Consultants - Phoenix
- Retina Associates Tucson - Tucson
Georgia
- Southeast Retina Center - Augusta
- Marietta Eye Clinic - Marietta
Illinois
- Retina Associated Ltd - Elmhurst
- University Retina and Macula Associates, PC - Oak Forest
Colorado
- Retina Consultants of Southern Colorado PC - Colorado Springs
Connecticut
- Retina Group of New England - Waterford
Maryland
- Cumberland Valley Retina PC - Hagerstown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2020-06-05 |
| Est. Completion | 2023-07-19 |
| Phase | Phase 2 |
What the finished NCT04265261 record still lists
NCT04265261 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04265261 names 20 study sites across 10 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04265261 about?
NCT04265261 is a clinical study titled "A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy". The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.
What is the current status of trial NCT04265261?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2020-06-05. Estimated completion is 2023-07-19.
What conditions does trial NCT04265261 study?
This clinical trial studies the following conditions: Diabetic Retinopathy.
What interventions are being tested in trial NCT04265261?
The interventions under investigation include: Placebo (DRUG), RG7774 (DRUG).
Who is sponsoring clinical trial NCT04265261?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04265261 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04265261's enrollment target sits among peer trials
139 33rd of 57 higher than 25 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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