Clinical trial NCT02435862: A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD (Posterior Vitreous Detachment) in Non-Proliferative Diabetic Retinopathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Proliferative Diabetic Retinopathy
Keywords: Vitreolysis of the Vitreous
Lead sponsor: Allegro Ophthalmics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: Trial Runners, LLC
First posted: 2015-05-06
Enrollment: 105
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Observation of pharmacologic induction of PVD.
timeFrame: 90 days
Secondary outcomes:
measure: 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.
timeFrame: 90 days
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: New London
country: United States
facility: New England Retina Associates
state: Connecticut
city: Lakeland
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Springfield
country: United States
facility: Illinois Retina Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Abilene
country: United States
facility: Retina Research Institute Of Texas
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Fairfax
country: United States
facility: The Retina Group of Washington
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
Study officials:
affiliation: Medical monitor
name: Vicken Karageozian, MD
role: STUDY_DIRECTOR
References: