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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.)
Information provided by:
Vitreoretinal Technologies, Inc. Identifier:
First received: April 18, 2008
Last updated: October 19, 2009
Last verified: October 2009
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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00664183

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
Bhubhneshwar, India
Sankara Nethralaya
Chennai, India
Coimbatore, India
Delhi, India
Hyderabad, India
Madurai, India
Pondicherry, India
Sponsors and Collaborators
Vitreoretinal Technologies, Inc.
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 Identifier: NCT00664183     History of Changes
Other Study ID Numbers: PVD-301
Study First Received: April 18, 2008
Last Updated: October 19, 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 processed this record on September 21, 2017