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COMPLETED Phase 3

A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders

NCT04516278 · View on ClinicalTrials.gov ↗

Study Summary

The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

Interventions

  • BIOLOGICAL bevacizumab

Study Locations (20)

California

  • Clinical Site — Beverly Hills
  • Clinical Site — Glendale
  • Clinical Site — Long Beach
  • Clinical Site — Palm Desert
  • Clinical Site — Poway

Texas

  • Clinical Site — Abilene
  • Clinical Site — Arlington
  • Clinical Site — McAllen
  • Clinical Site — San Antonio
  • Clinical Site — Willow Park

Florida

  • Clinical Site — Clearwater
  • Clinical Site — Winter Haven

Illinois

  • Clinical Site — Oak Forest
  • Clinical Site — Springfield

Arizona

  • Clinical Site — Tucson

Maryland

  • Clinical Site — Hagerstown

New Mexico

  • Clinical Site — Albuquerque

Pennsylvania

  • Clinical Site — Chambersburg

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2020-10-01
Est. Completion 2021-02-10
Phase Phase 3

Sponsor

Outlook Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04516278

The ClinicalTrials.gov registry entry for NCT04516278 describes a study currently listed as completed. It is categorized as Phase 3, 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 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Outlook Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention — of which bevacizumab 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: NCT04516278 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Texas, Florida. 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 NCT04516278 about?

NCT04516278 is a clinical study titled "A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders". The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

What is the current status of trial NCT04516278?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 195 participants. The study started on 2020-10-01. Estimated completion is 2021-02-10.

What conditions does trial NCT04516278 study?

This clinical trial studies the following conditions: Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Age-related Macular Degeneration, Wet Macular Degeneration, BRVO - Branch Retinal Vein Occlusion. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04516278?

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

Who is sponsoring clinical trial NCT04516278?

This trial is sponsored by Outlook Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04516278 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, 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