Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198471
• Other study ID #: ISTA-VIT-CS07
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: March 13, 2013
• Start date: July 2005
• Est. completion date: November 2006

Study information

• Verified date: March 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Vitreous Detachment

Intervention

Drug:
• Vitrase

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitreous detachment	The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28	Day 28	No