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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.
April 18, 2008
April 22, 2008
October 20, 2009
March 2008
December 2009   (Final data collection date for primary outcome measure)
Ultrasound [ Time Frame: 7 Months ]
Same as current
Complete list of historical versions of study NCT00664183 on ClinicalTrials.gov Archive Site
Ultrasound, OCT, Safety [ Time Frame: 7 Months ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Diabetic Retinopathy
Drug: Vitreosolve
Intravitreal injection
  • Experimental: 1
    Intervention: Drug: Vitreosolve
  • Experimental: 2
    Intervention: Drug: Vitreosolve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
400
Not Provided
December 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India,   United States
 
 
NCT00664183
PVD-301
No
Not Provided
Not Provided
Hampar Karageozian, CEO
Vitreoretinal Technologies, Inc.
Not Provided
Principal Investigator: Baruch Kupperman, MD University of California, Irvine
Principal Investigator: Naresh Mandova, MD University of Colorado, Denver
Vitreoretinal Technologies, Inc.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP