Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198471

Enrollment

Registered

2005-09-20

Start date

2005-07-31

Completion date

2006-11-30

Last updated

2013-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, Vitreous Detachment

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.

Interventions

DRUGVitrase

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Vitreous detachment	Day 28	The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026