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NCT02435862 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD (Posterior Vitreous Detachment) in Non-Proliferative Diabetic Retinopathy
A Phase 2 study of Non-Proliferative Diabetic Retinopathy, sponsored by Allegro Ophthalmics.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
- 12
- Study locations
NCT02435862: Completed Phase 2 study of Non-Proliferative Diabetic Retinopathy, sponsored by Allegro Ophthalmics.
NCT02435862 is a Phase 2 study of Non-Proliferative Diabetic Retinopathy that has completed, run by Allegro Ophthalmics. The registered enrollment target is 105 participants, below the 323-participant average among 4 other Non-Proliferative Diabetic Retinopathy trials with a reported enrollment target (67% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02435862, a Phase 2 study of Non-Proliferative Diabetic Retinopathy, has completed, sponsored by Allegro Ophthalmics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
- 12
- Study locations
Study Summary
A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.
Primary Outcome
The primary endpoint of this study is observation of pharmacologic induction of at least a stage 3 PVD, with PVD defined as a complete PVD to the equator except for vitreopapillary adhesion as seen on B-scan Ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center.
Conditions Studied
Interventions
- DRUG 1.0mg Luminate®
- DRUG 2.0mg Luminate®
- DRUG 3.0mg Luminate®
- OTHER Balanced Salt Solution for intravitreal injection in 0.10cc
Study Locations (12)
Texas
- Retina Research Institute Of Texas - Abilene
- Austin Retina Associates - Austin
- Valley Retina Institute - McAllen
- Medical Center Ophthalmology Associates - San Antonio
California
- Northern California Retina Vitreous Associates - Mountain View
- UCI Medical Center - Orange
Connecticut
- New England Retina Associates - New London
Florida
- Center for Retina and Macular Disease - Lakeland
Illinois
- Illinois Retina Center - Springfield
Indiana
- Midwest Eye Institute - Indianapolis
Virginia
- The Retina Group of Washington - Fairfax
Washington
- Spokane Eye Clinical Research - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2015-02-01 |
| Est. Completion | 2017-08-10 |
| Phase | Phase 2 |
What the finished NCT02435862 record still lists
NCT02435862 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 4 other Non-Proliferative Diabetic Retinopathy trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Non-Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 4 interventions - of which 1.0mg Luminate® is the first listed.
NCT02435862 lists 12 locations in 8 states (Texas, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02435862 about?
NCT02435862 is a clinical study titled "A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD (Posterior Vitreous Detachment) in Non-Proliferative Diabetic Retinopathy". A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.
What is the current status of trial NCT02435862?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2015-02-01. Estimated completion is 2017-08-10.
What conditions does trial NCT02435862 study?
This clinical trial studies the following conditions: Non-Proliferative Diabetic Retinopathy.
What interventions are being tested in trial NCT02435862?
The interventions under investigation include: 1.0mg Luminate® (DRUG), 2.0mg Luminate® (DRUG), 3.0mg Luminate® (DRUG), Balanced Salt Solution for intravitreal injection in 0.10cc (OTHER).
Who is sponsoring clinical trial NCT02435862?
This trial is sponsored by Allegro Ophthalmics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02435862 being conducted?
This trial has 12 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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