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

This study has been terminated.
(slow enrollment , interim analysis conducted.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00664183
First Posted: April 22, 2008
Last Update Posted: October 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vitreoretinal Technologies, Inc.
  Purpose
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.

Condition Intervention Phase
Diabetic Retinopathy Drug: Vitreosolve Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects

Resource links provided by NLM:


Further study details as provided by Vitreoretinal Technologies, Inc.:

Primary Outcome Measures:
  • Ultrasound [ Time Frame: 7 Months ]

Secondary Outcome Measures:
  • Ultrasound, OCT, Safety [ Time Frame: 7 Months ]

Estimated Enrollment: 400
Study Start Date: March 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Vitreosolve
Intravitreal injection
Experimental: 2 Drug: Vitreosolve
Intravitreal injection

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00664183


Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Beverly Hills, California, United States
Santa Ana, California, United States
United States, Florida
Gainesville, Florida, United States
Lakeland, Florida, United States
United States, Indiana
Indianapolis, Indiana, United States
New Albany, Indiana, United States
United States, North Carolina
Asheville, North Carolina, United States
United States, Texas
McAllen, Texas, United States
United States, Washington
Silverdale, Washington, United States
India
LVPEI
Bhubhneshwar, India
Sankara Nethralaya
Chennai, India
Aravind
Coimbatore, India
AIIMS
Delhi, India
LVPEI
Hyderabad, India
Aravind
Madurai, India
Aravind
Pondicherry, India
Sponsors and Collaborators
Vitreoretinal Technologies, Inc.
Investigators
Principal Investigator: Baruch Kupperman, MD University of California, Irvine
Principal Investigator: Naresh Mandova, MD University of Colorado, Denver
  More Information

Responsible Party: Hampar Karageozian, CEO
ClinicalTrials.gov Identifier: NCT00664183     History of Changes
Other Study ID Numbers: PVD-301
First Submitted: April 18, 2008
First Posted: April 22, 2008
Last Update Posted: October 20, 2009
Last Verified: October 2009

Keywords provided by Vitreoretinal Technologies, Inc.:
diabetic retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases