Status:
COMPLETED
Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Vitreous Detachment
Diabetic Retinopathy
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic r...
Eligibility Criteria
Inclusion
- Moderately severe to severe non-proliferative diabetic retinopathy
- Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) with pinhole of 20/320 or better in study eye \& 20/50 or better in non-study eye.
Exclusion
- Contraindications or hypersensitivities to Vitrase or anesthesia
- Any significant illness that could be expected to interfere with trial
- Prior Vitrase therapy
- Either a past diagnosis of clinically significant macular edema (CME) in study eye that required treatment or current CME that may require focal laser treatment within the next 30 days
- For either eye: ongoing ocular infection, inflammation or history of herpetic corneal lesion; an intravitreous injection within 30 days; glaucoma; intraocular pressure (IOP) of less than 5mmHg; retinal detachment or ocular tumors
- For study eye: vascular occlusive disease of fundus; corneal, lenticular or ocular media abnormalities; a significant ocular trauma within 6 months; previous vitrectomy; any prior laser treatment, cryo-retinopexy or any intraocular surgery; either a partial or complete posterior vitreous detachment (PVD); myopia of 6 or more spherical diopters and/or axial length exceeding 26mm; significant retinal pathology
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00198471
Start Date
July 1 2005
End Date
November 1 2006
Last Update
March 15 2013
Active Locations (4)
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1
Edgar L. Thomas, MD
Beverly Hills, California, United States, 90211
2
Ronni Lieberman, MD
New York, New York, United States, 10021
3
Valley Retina Institute, PA
McAllen, Texas, United States, 78503
4
The Virginia Retina Center
Leesburg, Virginia, United States, 20176