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
Conditions:Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:45 - Any
Updated:12/17/2017
Start Date:February 1, 2015
End Date:August 10, 2017

Use our guide to learn which trials are right for you!

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

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.


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
We found this trial at
12
sites
Springfield, Illinois
?
mi
from
Springfield, IL
Click here to add this to my saved trials
?
mi
from
Abilene, TX
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Fairfax, Virginia 22031
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
Indianapolis, Indiana 46290
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Lakeland, Florida 33805
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
McAllen, Texas 78503
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Mountain View, California 94040
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
New London, Connecticut 06320
?
mi
from
New London, CT
Click here to add this to my saved trials
Orange, California 92686
?
mi
from
Orange, CA
Click here to add this to my saved trials
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials