Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00198471
• Collaborator: (none)
• Enrollment: 10
• Locations: 4
• Arm: 1
• Duration (Months): 16
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitreous Detachment; Diabetic Retinopathy	Drug: Vitrase	Phase 2

Study Design

• Study Type: Interventional
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Assessment of Intravitreous Injections of Vitrase (Hyaluronidase for Injection) for Inducing Posterior Vitreous Detachment in Subjects With Moderate to Severe Non-proliferative Diabetic Retinopathy
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitrase A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.	Drug: Vitrase; Other Names: ovine hyaluronidase

Outcome Measures

Primary Outcome Measures

1. Vitreous detachment [Day 28]

   The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Jon Williams, PhD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00198471
• Other Study ID Numbers: ISTA-VIT-CS07
• First Posted: Sep 20, 2005
• Last Update Posted: Mar 15, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Vitreous Detachment; Dissociative Disorders

Study Results

No Results Posted as of Mar 15, 2013