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NCT05730218 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment
A Phase 2 study, sponsored by ONL Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
NCT05730218: Completed Phase 2 study, sponsored by ONL Therapeutics.
NCT05730218 is a Phase 2 study that has completed, run by ONL Therapeutics. The registered enrollment target is 136 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05730218, a Phase 2 study, has completed, sponsored by ONL Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
Study Summary
The goal of this Phase 2 clinical trial is to learn about ONL1204 Ophthalmic Solution in terms of safety and how well the drug works in patients that have a macula-off (central point of vision) rhegmatogenous retinal detachment (RRD). The main questions it aims to answer are: * Does ONL1204 improve vision in macula-off RRD patients when used before retinal detachment repair surgery compared to patients that have surgery alone? * Is ONL1204 safe to use as an add-on drug before retinal repair surgery? Researchers will observe patients that receive two different dosages of ONL1204 Ophthalmic Solution (50 µg or 200 µg) compared to current standard therapy (no treatment) to see if there are differences in vision and safety outcomes.
Primary Outcome
Mean AULCSF as measured with the Adaptive Sensory Technology (AST) Manifold Contrast Vision Meter at Week 24 for subjects who do not have primary surgical failure.
Interventions
- DRUG Sham treatment
- DRUG ONL1204 Ophthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2024-02-21 |
| Phase | Phase 2 |
What the finished NCT05730218 record still lists
NCT05730218 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Sham treatment is the first listed.
NCT05730218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05730218 about?
NCT05730218 is a clinical study titled "A Phase 2 Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects With Mac-off Retinal Detachment". The goal of this Phase 2 clinical trial is to learn about ONL1204 Ophthalmic Solution in terms of safety and how well the drug works in patients that have a macula-off (central point of vision) rhegmatogenous retinal detachment (RRD). The main questions it aims to answer are: * Does ONL1204 improve...
What is the current status of trial NCT05730218?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2023-04-04. Estimated completion is 2024-02-21.
What interventions are being tested in trial NCT05730218?
The interventions under investigation include: Sham treatment (DRUG), ONL1204 Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT05730218?
This trial is sponsored by ONL Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05730218's enrollment target sits among peer trials
136 527th of 2000 higher than 1,469 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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