A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD (Posterior Vitreous Detachment) in Non-Proliferative Diabetic Retinopathy

Completed · Phase 2

Conditions studied: Non-Proliferative Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT02435862

Run by

Allegro Ophthalmics, LLC

People needed

105

Starts

2015-02-01

Expected to finish

2017-08-10

Last updated by the study team

2017-12-15

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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
• Subjects likely to need intraocular surgery, laser treatment, or non-study intravitreal injections in the study eye during the study period.
• Subjects with history of retinal detachment in the study eye
• High myopes with a spherical equivalent of > -8.00 D spectacle correction in the study eye
• Subjects with systolic BP> 180 at screening
• Subjects with HgA1c >12.0 within 90 days preceding enrollment
• Subjects that have chronic or recurrent uveitis
• Subjects that have ongoing ocular infection or inflammation
• Subjects with uncontrolled glaucoma, ie IOP > 25mm with or without IOP lowering agents
• Subjects that have contraindications to the study medication
• Subjects who are unable to meet the extensive post-op evaluation regimen
• Pregnant or nursing women
• Subjects with a history of penetrating ocular trauma in the study eye
• Subjects that are participating in another clinical research study

Where it is running

• 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
• 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
• The Retina Group of Washington — Fairfax, Virginia, United States
• Spokane Eye Clinical Research — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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