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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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,506-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (92% lower). The listed sponsor is Outlook Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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