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

• Status: Completed
• Trial end date: 2017-08-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allegro Ophthalmics, LLC
• Collaborators: Duke University; Trial Runners, LLC
• Treatments: Pharmaceutical Solutions

Criteria

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