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

This study has been terminated.

( slow enrollment , interim analysis conducted. )

First Received on April 18, 2008. Last Updated on October 19, 2009 History of Changes

Sponsor:	Vitreoretinal Technologies, Inc.
Information provided by:	Vitreoretinal Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00664183

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 II Phase III

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:

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders Ultrasound

U.S. FDA Resources

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

Primary Outcome Measures:

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

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 February 09, 2012