Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

Phase 2

Completed

• Conditions: Vitreous Detachment; Diabetic Retinopathy
• Interventions: Drug: Vitrase

• Registration Number: NCT00198471
• Lead Sponsor: Bausch & Lomb Incorporated

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 retinopathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitrase	Vitrase	A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.

Primary Outcome Measures

Name	Time	Method
Vitreous detachment	Day 28	The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28

Trial Locations

Locations (4)

Edgar L. Thomas, MD; 🇺🇸 Beverly Hills, California, United States

Valley Retina Institute, PA; 🇺🇸 McAllen, Texas, United States

Ronni Lieberman, MD; 🇺🇸 New York, New York, United States

The Virginia Retina Center; 🇺🇸 Leesburg, Virginia, United States