Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

Bausch + Lomb

Status and phase

Completed

Phase 2

Conditions

Vitreous Detachment

Diabetic Retinopathy

Treatments

Drug: Vitrase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00198471

ISTA-VIT-CS07

Details and patient eligibility

About

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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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