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NCT03531294 · ClinicalTrials.gov registry record · Phase 2
Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement
A Phase 2 study, sponsored by Greater Houston Retina Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT03531294: Completed Phase 2 study, sponsored by Greater Houston Retina Research.
NCT03531294 is a Phase 2 study that has completed, run by Greater Houston Retina Research. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03531294, a Phase 2 study, has completed, sponsored by Greater Houston Retina Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA.
Primary Outcome
Assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA
Interventions
- DRUG Aflibercept Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-05-23 |
| Est. Completion | 2021-04-09 |
| Phase | Phase 2 |
What the finished NCT03531294 record still lists
NCT03531294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Aflibercept Injection is the first listed.
NCT03531294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03531294 about?
NCT03531294 is a clinical study titled "Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement". The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fund...
What is the current status of trial NCT03531294?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-05-23. Estimated completion is 2021-04-09.
What interventions are being tested in trial NCT03531294?
The interventions under investigation include: Aflibercept Injection (DRUG).
Who is sponsoring clinical trial NCT03531294?
This trial is sponsored by Greater Houston Retina Research, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03531294's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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