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

Non-Proliferative Diabetic Retinopathy Clinical Trial

Official title:

Protocol PVD-202: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD in Non-Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435862
• Other study ID #: PVD-202
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2015
• Last updated: December 13, 2017
• Start date: February 1, 2015
• Est. completion date: August 10, 2017

Study information

• Verified date: December 2017
• Source: Allegro Ophthalmics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 10, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Non-Proliferative Diabetic Retinopathy
• Retinal Diseases
• Vitreous Detachment

Intervention

Drug:
• 1.0mg Luminate®

• 2.0mg Luminate®

• 3.0mg Luminate®

Other:
• Balanced Salt Solution for intravitreal injection in 0.10cc

Locations

Country	Name	City	State
United States	Retina Research Institute Of Texas	Abilene	Texas
United States	Austin Retina Associates	Austin	Texas
United States	The Retina Group of Washington	Fairfax	Virginia
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Center for Retina and Macular Disease	Lakeland	Florida
United States	Valley Retina Institute	McAllen	Texas
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	New England Retina Associates	New London	Connecticut
United States	UCI Medical Center	Orange	California
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Illinois Retina Center	Springfield	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Allegro Ophthalmics, LLC	Duke University, Trial Runners, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation of pharmacologic induction of PVD.	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.	90 days
Secondary	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.	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