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

Phase 2

Terminated

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Vitreosolve

• Registration Number: NCT00664183
• 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: 2008-03
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-22
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-19
• Last Update Posted: 2009-10-20
• Primary Completion: 2009-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 400

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 PVD at baseline exam in the study eye.

Exclusion Criteria

• Subjects with Retinal pathology in the study eye other than (NPDR)
• Subjects with high myopia in the study eye
• Subjects who have monocular vision or contra 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 than 6 months prior to study enrollment
• Subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments in the study eye.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vitreosolve	-
2	Vitreosolve	-

Primary Outcome Measures

Name	Time	Method
Ultrasound	7 Months

Secondary Outcome Measures

Name	Time	Method
Ultrasound, OCT, Safety	7 Months

Trial Locations

Locations (4)

LVPEI; 🇮🇳 Hyderabad, India

Aravind; 🇮🇳 Pondicherry, India

Sankara Nethralaya; 🇮🇳 Chennai, India

AIIMS; 🇮🇳 Delhi, India