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ACTIVE NOT RECRUITING Phase 3

A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

NCT05112861 · View on ClinicalTrials.gov ↗

Study Summary

The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes 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 (3)

Illinois

  • Clinical Site — Springfield

Maryland

  • Clinical Site — Hagerstown

Pennsylvania

  • Clinical Site — Chambersburg

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2021-11-15
Est. Completion 2025-03
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 NCT05112861

The ClinicalTrials.gov registry entry for NCT05112861 describes a study currently listed as active not recruiting. 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 120 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: NCT05112861 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Illinois, Maryland, Pennsylvania. 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 NCT05112861 about?

NCT05112861 is a clinical study titled "A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders". The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes 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, ...

What is the current status of trial NCT05112861?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2021-11-15. Estimated completion is 2025-03.

What conditions does trial NCT05112861 study?

This clinical trial studies the following conditions: Diabetic Macular Edema, Age-Related Macular Degeneration, Neovascular 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 NCT05112861?

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 NCT05112861?

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 NCT05112861 being conducted?

This trial has 3 study locations across Illinois, Maryland, Pennsylvania. 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