Non-Proliferative Diabetic Retinopathy
Conditions
Keywords
Vitreolysis of the Vitreous
Brief 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.
Interventions
DRUG1.0mg Luminate®
DRUG2.0mg Luminate®
DRUG3.0mg Luminate®
OTHERBalanced Salt Solution for intravitreal injection in 0.10cc
Sponsors
Duke University
Trial Runners, LLC
Allegro Ophthalmics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Non-Proliferative Diabetic Retinopathy Subjects of any grade 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
1. No media opacities or abnormalities that would preclude observation of the retina or performance of any study related imaging tests 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observation of pharmacologic induction of PVD. | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Outcome results
None listed