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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
105
Northern California Retina Vitreous Associates
Mountain View, California, United States
UCI Medical Center
Orange, California, United States
New England Retina Associates
New London, Connecticut, United States
Observation of pharmacologic induction of PVD.
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.
Time frame: 90 days
The secondary endpoints of this study is the observation of a complete stage 4 PVD to the equator including vitreopapillary release as seen by B-scan ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center.
The secondary endpoints of this study is the observation of a complete stage 4 PVD to the equator including vitreopapillary release as seen by B-scan ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center.
Time frame: 90 days
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Center for Retina and Macular Disease
Lakeland, Florida, United States
Illinois Retina Center
Springfield, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Retina Research Institute Of Texas
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Valley Retina Institute
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
...and 2 more locations