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NCT05112861 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Age-related Macular Degeneration and Diabetic Macular Edema, sponsored by Outlook Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT05112861: Active Phase 3 study of Age-related Macular Degeneration and Diabetic Macular Edema, sponsored by Outlook Therapeutics.
NCT05112861 is a Phase 3 study of Age-related Macular Degeneration and Diabetic Macular Edema that is active but no longer recruiting, run by Outlook Therapeutics. The registered enrollment target is 120 participants, below the 1,506-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05112861, a Phase 3 study of Age-related Macular Degeneration and Diabetic Macular Edema, is active but no longer recruiting, sponsored by Outlook Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
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.
Conditions Studied
Interventions
- BIOLOGICAL bevacizumab
Study Locations (3)
Illinois
- Clinical Site - Springfield
Maryland
- Clinical Site - Hagerstown
Pennsylvania
- Clinical Site - Chambersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2025-03 |
| Phase | Phase 3 |
What the registry record for NCT05112861 still lists
NCT05112861 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,506-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (92% lower).
The record links to 5 conditions, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which bevacizumab is the first listed.
NCT05112861 reports a single indexed study location in Illinois, Maryland, Pennsylvania.
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: Age-related Macular Degeneration, Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Wet Macular Degeneration, BRVO - Branch Retinal Vein Occlusion.
What interventions are being tested in trial NCT05112861?
The interventions under investigation include: bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05112861?
This trial is sponsored by Outlook Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05112861's enrollment target sits among peer trials
120 28th of 74 higher than 47 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
COMPLETED · Phase 3
-
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
COMPLETED · Phase 3
-
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
COMPLETED · Phase 3
-
Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD
COMPLETED · Phase 3
-
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
COMPLETED · Phase 3
-
Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD
RECRUITING · Phase 2
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