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
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 |
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Bausch & Lomb Incorporated |
United States,
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 |
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