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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.

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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

FieldValue
Enrollment Target 40 participants
Start Date 2018-05-23
Est. Completion 2021-04-09
Phase Phase 2

Sponsor

Greater Houston Retina Research

8 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.