Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment (NCT00198471) | Clinical Trial Compass
CompletedPhase 2
Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment
United States10 participantsStarted 2005-07
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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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