A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects

Phase 3

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Vitreosolve

• Registration Number: NCT00908778
• Lead Sponsor: Vitreoretinal Technologies, Inc.

Brief Summary

The purpose of this study is to determine the safety and efficacy of Vitreosolve® in diabetic retinopathy patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-19
• Last Update Posted: 2009-10-20
• Primary Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Subjects with a history of systemic diabetes(type I,or II)
• Subject with a documented history of Non- proliferative Diabetic Retinopathy(NPDR)
• Subjects with no or partial PVD at baseline exam in study eye.

Exclusion Criteria

• Subjects with retinal pathology in the study eye other then (NPDR)
• Subjects with high myopia in the study eye
• Subjects who have monocular vision or central lateral vision of 20/200 or worse BCVA in the non-study eye.
• Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less then 6 months prior to study enrollment.
• Subjects that have either vitrectomy surgery, intavitreal injections, or laser treatments in the study eye.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitreosolve I	Vitreosolve	Intravitreal injection
Vitreosolve	Vitreosolve	Intravitreal injection

Primary Outcome Measures

Name	Time	Method
Ultrasound, OCT, and clinical exam	6 months

Secondary Outcome Measures

Name	Time	Method
Ultrasound ,OCT ,Safety, and Clinical Exam	6 months

Trial Locations

Locations (5)

Hidalgo; 🇲🇽 Monterrey, Neuvo Leon, Mexico

La Ceguera; 🇲🇽 San Lucas, Coyoacan, Mexico

LVPEI; 🇮🇳 Vizag, AP, India

Conde De Valenciana; 🇲🇽 Mexico City, DF, Mexico

Amrita; 🇮🇳 Kochi, India