A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD … (NCT02435862) | Clinical Trial Compass
CompletedPhase 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
United States105 participantsStarted 2015-02-01
Plain-language 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.
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. Non-Proliferative Diabetic Retinopathy Subjects of any grade
✓. Subjects with either a) no PVD, b) stage 1 PVD or c) stage 2 PVD at baseline by b-scan in the study eye
✓. Subjects that are at least 45 years of age
✓. Subjects that are free of other significant retinal pathologies that could interfere with the measurements or conduct of this study
✓. Intraocular Pressure under control, IOP 30 mm or less
✓. Male or female subjects
✓. Signed Informed Consent -
Exclusion criteria
✕. No media opacities or abnormalities that would preclude observation of the retina or performance of any study related imaging tests
✕. History of prior vitrectomy in the study eye
✕. Subjects with epiretinal membranes, vitreomacular adhesion, vitreomacular traction, or macular holes in the study eye at baseline
✕. Subjects with proliferative DR, neovascular AMD, or retinal vascular occlusion in the study eye
✕. Subjects with clinically significant macular edema in the study eye
✕. Subjects with a history of focal/grid or pan-retinal laser photocoagulation in the study eye