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ACTIVE NOT RECRUITING Phase 2

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

NCT05393284 · View on ClinicalTrials.gov ↗

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.

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. 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 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valo Health, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT05393284 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Texas, California, Colorado. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05393284?

The interventions under investigation include: Placebo (DRUG), OPL-0401 Dose 1 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05393284?

This trial is sponsored by Valo Health, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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