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NCT05409235 · ClinicalTrials.gov registry record · Phase 2
Nesvategrast (OTT166) in Diabetic Retinopathy (DR)
A Phase 2 study, sponsored by OcuTerra Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 225
- Enrollment target
NCT05409235: Completed Phase 2 study, sponsored by OcuTerra Therapeutics.
NCT05409235 is a Phase 2 study that has completed, run by OcuTerra Therapeutics. The registered enrollment target is 225 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05409235, a Phase 2 study, has completed, sponsored by OcuTerra Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 225 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.
Primary Outcome
To characterize the efficacy of topical OTT166 in participants with DR, the Diabetic Retinopathy Severity Scale (DRSS) was used. The DRSS ranges from 10 to 85 in 12 discrete steps with higher score representing worse DR. The DRSS values were determined by the central reading center. The data reported are the estimated percentage of participants that improved by at least 2 steps from baseline. The reported data include the use of imputation according to the primary estimand as described in the pr
Interventions
- DRUG Vehicle control
- DRUG OTT166
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2022-07-29 |
| Est. Completion | 2023-12-29 |
| Phase | Phase 2 |
What the finished NCT05409235 record still lists
NCT05409235 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% higher).
The record links to 0 conditions, and to 2 interventions - of which Vehicle control is the first listed.
NCT05409235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05409235 about?
NCT05409235 is a clinical study titled "Nesvategrast (OTT166) in Diabetic Retinopathy (DR)". This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.
What is the current status of trial NCT05409235?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2022-07-29. Estimated completion is 2023-12-29.
What interventions are being tested in trial NCT05409235?
The interventions under investigation include: Vehicle control (DRUG), OTT166 (DRUG).
Who is sponsoring clinical trial NCT05409235?
This trial is sponsored by OcuTerra Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05409235's enrollment target sits among peer trials
225 267th of 2000 higher than 1,732 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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