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

Allegro Ophthalmics

Status and phase: Completed; Phase 2

Conditions: Non-Proliferative Diabetic Retinopathy

Treatments: Drug: 3.0mg Luminate®; Drug: 2.0mg Luminate®; Drug: 1.0mg Luminate®; Other: Balanced Salt Solution for intravitreal injection in 0.10cc

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02435862

PVD-202

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

105 participants in 4 patient groups, including a placebo group

1.0mg Luminate®

Experimental group

Description:

1.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)

Treatment:

Drug: 1.0mg Luminate®

2.0mg Luminate®

Experimental group

Description:

2.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)

Treatment:

Drug: 2.0mg Luminate®

3.0mg Luminate®

Experimental group

Description:

3.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)

Treatment:

Drug: 3.0mg Luminate®

Balanced Salt Solution 0.10cc

Placebo Comparator group

Description:

Balanced Salt Solution 0.10cc injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)

Treatment:

Other: Balanced Salt Solution for intravitreal injection in 0.10cc