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

Study Overview
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Brief Summary
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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.

Official Title
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Protocol PVD-202: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD in Non-Proliferative Diabetic Retinopathy

Conditions
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Non-Proliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: 1.0mg Luminate®
* Drug: 2.0mg Luminate®
* Drug: 3.0mg Luminate®
* Other: Balanced Salt Solution for intravitreal injection in 0.10cc


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0mg Luminate®<br>1.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) | Drug: 1.0mg Luminate®<br> <br> |
| Experimental: 2.0mg Luminate®<br>2.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) | Drug: 2.0mg Luminate®<br> <br> |
| Experimental: 3.0mg Luminate®<br>3.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) | Drug: 3.0mg Luminate®<br> <br> |
| Placebo Comparator: Balanced Salt Solution 0.10cc<br>Balanced Salt Solution 0.10cc injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) | Other: Balanced Salt Solution for intravitreal injection in 0.10cc<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitreolysis of the Vitreous