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NCT04516278 · ClinicalTrials.gov registry record · Phase 3
A 3-month Study to Assess the Safety of ONS-5010 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.
- Completed
- Registry status
- Phase 3
- Development phase
- 195
- Enrollment target
- 20
- Study locations
NCT04516278 is a Phase 3 study of Age-related Macular Degeneration and Diabetic Macular Edema that has completed, run by Outlook Therapeutics. The registered enrollment target is 195 participants, below the 1,505-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT04516278, a Phase 3 study of Age-related Macular Degeneration and Diabetic Macular Edema, has completed, sponsored by Outlook Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 195 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2021-02-10 |
| Phase | Phase 3 |
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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, categorized as Phase 3. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,505-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (87% 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.
NCT04516278 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Texas, Florida.
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: 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 NCT04516278?
The interventions under investigation include: bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04516278?
This trial is sponsored by Outlook Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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