Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

Completed · Phase 2

Conditions studied: Vitreous Detachment, Diabetic Retinopathy

In brief

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 retinopathy.

Key facts

Study ID

NCT00198471

Run by

Bausch & Lomb Incorporated

People needed

10

Starts

2005-07-01

Expected to finish

2006-11-01

Last updated by the study team

2013-03-15

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Edgar L. Thomas, MD — Beverly Hills, California, United States
• Ronni Lieberman, MD — New York, New York, United States
• Valley Retina Institute, PA — McAllen, Texas, United States
• The Virginia Retina Center — Leesburg, Virginia, United States

Full record on ClinicalTrials.gov

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