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NCT05393284 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy

A Phase 2 study of Proliferative Diabetic Retinopathy and Non-Proliferative Diabetic Retinopathy, sponsored by Valo Health.

Active
Registry status
Phase 2
Development phase
114
Enrollment target
20
Study locations

NCT05393284 is a Phase 2 study of Proliferative Diabetic Retinopathy and Non-Proliferative Diabetic Retinopathy that is active but no longer recruiting, run by Valo Health. The registered enrollment target is 114 participants, below the 194-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT05393284, a Phase 2 study of Proliferative Diabetic Retinopathy and Non-Proliferative Diabetic Retinopathy, is active but no longer recruiting, sponsored by Valo Health.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
114 participants
Enrollment target
20
Study locations

Study Summary

OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.

Conditions Studied

Proliferative Diabetic Retinopathy Non-Proliferative Diabetic Retinopathy

Interventions

  • DRUG Placebo
  • DRUG OPL-0401 Dose 1

Study Locations (20)

Texas

  • Austin Retina Associates - Austin
  • Austin Clinical Research, LLC - Austin
  • Texas Retina Associates - Dallas
  • Valley Retina Institute, PA - McAllen
  • Austin Retina Associates - Round Rock - Round Rock
  • Medical Center Ophthalmology Associates - San Antonio

California

  • Northern California Retina Vitreous Associates - Mountain View
  • Retina Consultants of Southern California - Riverside
  • Southern California Permanente Medical Group - Riverside
  • Retinal Consultants Medical Group - Sacramento
  • California Retina Consultants - Santa Barbara

Colorado

  • Panorama Eye Care, LLC - Fort Collins

Florida

  • Mid Florida Eye Center - Mt. Dora

Louisiana

  • Eye Associates of Northeast Louisiana - West Monroe

Maryland

  • The Retina Care Center - Baltimore

Massachusetts

  • Massachussetts Eye and Ear - Boston

Michigan

  • Retina Associates of Michigan - Grand Blanc

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2022-08-16
Est. Completion 2024-08
Phase Phase 2

Sponsor

Valo Health

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05393284

The ClinicalTrials.gov registry entry for NCT05393284 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 194-participant average among 5 other Proliferative Diabetic Retinopathy trials with a reported enrollment target (41% lower). The listed sponsor is Valo Health, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05393284 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Texas, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT05393284 about?

NCT05393284 is a clinical study titled "Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy". OPL-0401-201 is a multicenter study to investigate the safety and efficacy of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.

What is the current status of trial NCT05393284?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2022-08-16. Estimated completion is 2024-08.

What conditions does trial NCT05393284 study?

This clinical trial studies the following conditions: Proliferative Diabetic Retinopathy, Non-Proliferative Diabetic Retinopathy.

What interventions are being tested in trial NCT05393284?

The interventions under investigation include: Placebo (DRUG), OPL-0401 Dose 1 (DRUG).

Who is sponsoring clinical trial NCT05393284?

This trial is sponsored by Valo Health, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05393284 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Louisiana, Maryland. 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.