Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment
Vitreous Detachment, Diabetic Retinopathy
About this trial
This is an interventional treatment trial for Vitreous Detachment
Eligibility Criteria
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
Sites / Locations
- Edgar L. Thomas, MD
- Ronni Lieberman, MD
- Valley Retina Institute, PA
- The Virginia Retina Center
Arms of the Study
Arm 1
Experimental
Vitrase
A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.