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

Phase 2

Completed

• Conditions: Non-Proliferative Diabetic Retinopathy
• Interventions: Drug: 2.0mg Luminate®; Drug: 3.0mg Luminate®; Drug: 1.0mg Luminate®; Other: Balanced Salt Solution for intravitreal injection in 0.10cc

• Registration Number: NCT02435862
• Lead Sponsor: Allegro Ophthalmics, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-01
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-06
• Primary Completion: 2017-08-10
• Study Completion: 2017-08-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.0mg 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)
3.0mg 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)
1.0mg Luminate®	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)
Balanced Salt Solution 0.10cc	Balanced Salt Solution for intravitreal injection in 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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

New England Retina Associates; 🇺🇸 New London, Connecticut, United States

UCI Medical Center; 🇺🇸 Orange, California, United States

Illinois Retina Center; 🇺🇸 Springfield, Illinois, United States

Valley Retina Institute; 🇺🇸 McAllen, Texas, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

Midwest Eye Institute; 🇺🇸 Indianapolis, Indiana, United States

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States

The Retina Group of Washington; 🇺🇸 Fairfax, Virginia, United States

Center for Retina and Macular Disease; 🇺🇸 Lakeland, Florida, United States

Retina Research Institute Of Texas; 🇺🇸 Abilene, Texas, United States

Spokane Eye Clinical Research; 🇺🇸 Spokane, Washington, United States

Austin Retina Associates; 🇺🇸 Austin, Texas, United States