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Clinical Trial Details

NCT ID: NCT00908778
Date Last Changed: October 19, 2009

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Diabetic Retinopathy

Research Study Title

A Phase 3 Safety and Efficacy Study of Vitreosolve® for Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.

Purpose

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

To Learn more

Recruitment Details

Phase
3
Gender
Both Male and Female
Age
50 and up
Overall Status
Recruiting
Lead Sponsor
Vitreoretinal Technologies, Inc.
Duration
21 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 50 Years and up

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.

Site Locations (5)

Country State City Zip Facility and Contact
India AP Vizag LVPEI
India Kochi Amrita
Mexico Coyoacan San Lucas La Ceguera
Mexico DF Mexico City Conde De Valenciana
Mexico Neuvo Leon Monterrey Hidalgo

Contact

Philip N Calvillo
949-753-1008 ext. 120
E-mail:

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