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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 is a Phase 2 study that has completed, run by Greater Houston Retina Research. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03531294
The ClinicalTrials.gov registry entry for NCT03531294 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Greater Houston Retina Research, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aflibercept Injection is the first listed.
NCT03531294 reports 0 study locations.
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.
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