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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 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.

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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.

Conditions Studied

Diabetic Retinopathy

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

FieldValue
Enrollment Target 139 participants
Start Date 2020-06-05
Est. Completion 2023-07-19
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04265261

The ClinicalTrials.gov registry entry for NCT04265261 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (92% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.