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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:
Information provided by:
Vitreoretinal Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00664183
First received: April 18, 2008
Last updated: October 19, 2009
Last verified: October 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Ultrasound [ Time Frame: 7 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ultrasound, OCT, Safety [ Time Frame: 7 Months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hampar Karageozian, CEO
ClinicalTrials.gov Identifier: NCT00664183     History of Changes
Other Study ID Numbers: PVD-301
Study First Received: April 18, 2008
Last Updated: October 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Vitreoretinal Technologies, Inc.:
diabetic retinopathy

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

ClinicalTrials.gov processed this record on May 16, 2013