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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Vitreoretinal Technologies, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vitreoretinal Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00908778
First received: May 26, 2009
Last updated: October 19, 2009
Last verified: October 2009

May 26, 2009
October 19, 2009
October 2008
July 2010   (final data collection date for primary outcome measure)
Ultrasound, OCT, and clinical exam [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00908778 on ClinicalTrials.gov Archive Site
Ultrasound ,OCT ,Safety, and Clinical Exam [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.

The purpose of this study is to determine the safety and efficacy of Vitreosolve® in diabetic retinopathy patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Diabetic Retinopathy
Drug: Vitreosolve
intravitreal injection
  • Experimental: Vitreosolve I
    Intravitreal injection
    Intervention: Drug: Vitreosolve
  • Experimental: Vitreosolve
    Intravitreal injection
    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.
 
Recruiting
160
Not Provided
July 2010   (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 or partial PVD at baseline exam in study eye.

Exclusion Criteria:

  • Subjects with retinal pathology in the study eye other then (NPDR)
  • Subjects with high myopia in the study eye
  • Subjects who have monocular vision or central 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 then 6 months prior to study enrollment.
  • Subjects that have either vitrectomy surgery, intavitreal injections, or laser treatments in the study eye.
Both
50 Years and older
No
Contact: Philip N Calvillo 949-753-1008 ext 120 Philip@vrtco.com
India,   Mexico
 
NCT00908778
PVD- 302
No
Hampar Karageozian, CEO
Vitreoretinal Technologies, Inc.
Not Provided
Principal Investigator: Hugo Quiroz-Mercado, MD APEC, Hospital La Ceguera
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