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 Ophthalmic Intravitreal Injection in Retinopathy Subjects

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2
  • 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 Locations

  • India
      • Bhubhneshwar, India
        • LVPEI
      • Chennai, India
        • Sankara Nethralaya
      • Coimbatore, India
        • Aravind
      • Delhi, India
        • AIIMS
      • Hyderabad, India
        • LVPEI
      • Madurai, India
        • Aravind
      • Pondicherry, India
        • Aravind
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Santa Ana, California, United States
    • Florida
      • Gainesville, Florida, United States
      • Lakeland, Florida, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • New Albany, Indiana, United States
    • North Carolina
      • Asheville, North Carolina, United States
    • Texas
      • McAllen, Texas, United States
    • Washington
      • Silverdale, Washington, United States

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

30 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 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 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: 1
Drug: Vitreosolve
Intravitreal injection
Experimental: 2
Drug: Vitreosolve
Intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ultrasound
Time Frame: 7 Months
7 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ultrasound, OCT, Safety
Time Frame: 7 Months
7 Months

Collaborators and Investigators

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

Sponsor

Vitreoretinal Technologies, Inc.

Investigators

  • Principal Investigator: Baruch Kupperman, MD, University of California, Irvine
  • Principal Investigator: Naresh Mandova, MD, University of Colorado, Denver

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

March 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 22, 2008

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-301

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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