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COMPLETED 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

NCT04265261 · View on ClinicalTrials.gov ↗

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

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

758 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04265261 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04265261?

The interventions under investigation include: Placebo (DRUG), RG7774 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04265261?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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