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

October 19, 2009 updated by: Vitreoretinal Technologies, Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Philip N Calvillo
  • Phone Number: 120 949-753-1008
  • Email: Philip@vrtco.com

Study Locations

  • India
      • Kochi, India
        • Recruiting
        • Amrita
    • AP
      • Vizag, AP, India
        • Recruiting
        • LVPEI
  • Mexico
    • Coyoacan
      • San Lucas, Coyoacan, Mexico
        • Recruiting
        • La Ceguera
    • DF
      • Mexico City, DF, Mexico
        • Recruiting
        • Conde De Valenciana
    • Neuvo Leon
      • Monterrey, Neuvo Leon, Mexico
        • Recruiting
        • Hidalgo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitreosolve I
Intravitreal injection
Drug: Vitreosolve
intravitreal injection
Experimental: Vitreosolve
Intravitreal injection
Drug: Vitreosolve
intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ultrasound, OCT, and clinical exam
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ultrasound ,OCT ,Safety, and Clinical Exam
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitreoretinal Technologies, Inc.

Investigators

  • Principal Investigator: Naresh Mandova, MD, University of Colorado, Denver
  • Principal Investigator: Hugo Quiroz-Mercado, MD, APEC, Hospital La Ceguera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

October 20, 2009

Last Update Submitted That Met QC Criteria

October 19, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PVD- 302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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