A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD (Posterior Vitreous Detachment) in Non-Proliferative Diabetic Retinopathy
NCT ID: NCT02435862
Last Updated: 2017-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2015-02-01
2017-08-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1.0mg Luminate®
1.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
1.0mg Luminate®
2.0mg Luminate®
2.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
2.0mg Luminate®
3.0mg Luminate®
3.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
3.0mg Luminate®
Balanced Salt Solution 0.10cc
Balanced Salt Solution 0.10cc injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
Balanced Salt Solution for intravitreal injection in 0.10cc
Interventions
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1.0mg Luminate®
2.0mg Luminate®
3.0mg Luminate®
Balanced Salt Solution for intravitreal injection in 0.10cc
Eligibility Criteria
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Inclusion Criteria
2. Subjects with either a) no PVD, b) stage 1 PVD or c) stage 2 PVD at baseline by b-scan in the study eye
3. Subjects that are at least 45 years of age
4. Subjects that are free of other significant retinal pathologies that could interfere with the measurements or conduct of this study
5. Intraocular Pressure under control, IOP 30 mm or less
6. Male or female subjects
7. Signed Informed Consent -
Exclusion Criteria
2. History of prior vitrectomy in the study eye
3. Subjects with epiretinal membranes, vitreomacular adhesion, vitreomacular traction, or macular holes in the study eye at baseline
4. Subjects with proliferative DR, neovascular AMD, or retinal vascular occlusion in the study eye
5. Subjects with clinically significant macular edema in the study eye
6. Subjects with a history of focal/grid or pan-retinal laser photocoagulation in the study eye
7. Subjects likely to need intraocular surgery, laser treatment, or non-study intravitreal injections in the study eye during the study period.
8. Subjects with history of retinal detachment in the study eye
9. High myopes with a spherical equivalent of \> -8.00 D spectacle correction in the study eye
10. Subjects with systolic BP\> 180 at screening
11. Subjects with HgA1c \>12.0 within 90 days preceding enrollment
12. Subjects that have chronic or recurrent uveitis
13. Subjects that have ongoing ocular infection or inflammation
14. Subjects with uncontrolled glaucoma, ie IOP \> 25mm with or without IOP lowering agents
15. Subjects that have contraindications to the study medication
16. Subjects who are unable to meet the extensive post-op evaluation regimen
17. Pregnant or nursing women
18. Subjects with a history of penetrating ocular trauma in the study eye
19. Subjects that are participating in another clinical research study
45 Years
ALL
No
Sponsors
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Duke University
OTHER
Trial Runners, LLC
OTHER
Allegro Ophthalmics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Vicken Karageozian, MD
Role: STUDY_DIRECTOR
Medical monitor
Locations
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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
Countries
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Other Identifiers
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PVD-202
Identifier Type: -
Identifier Source: org_study_id