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

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.
ClinicalTrials.gov Identifier: NCT00908778
Recruitment Status : Unknown
Verified October 2009 by Vitreoretinal Technologies, Inc..
Recruitment status was:  Recruiting
First Posted : May 27, 2009
Last Update Posted : October 20, 2009
Information provided by:
Vitreoretinal Technologies, Inc.

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

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Vitreosolve Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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 Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.
Study Start Date : October 2008
Estimated Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vitreosolve I
Intravitreal injection
Drug: Vitreosolve
intravitreal injection
Experimental: Vitreosolve
Intravitreal injection
Drug: Vitreosolve
intravitreal injection

Primary Outcome Measures :
  1. Ultrasound, OCT, and clinical exam [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Ultrasound ,OCT ,Safety, and Clinical Exam [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908778

Contact: Philip N Calvillo 949-753-1008 ext 120 Philip@vrtco.com

LVPEI Recruiting
Vizag, AP, India
Amrita Recruiting
Kochi, India
La Ceguera Recruiting
San Lucas, Coyoacan, Mexico
Conde De Valenciana Recruiting
Mexico City, DF, Mexico
Hidalgo Recruiting
Monterrey, Neuvo Leon, Mexico
Sponsors and Collaborators
Vitreoretinal Technologies, Inc.
Principal Investigator: Hugo Quiroz-Mercado, MD APEC, Hospital La Ceguera
Principal Investigator: Naresh Mandova, MD University of Colorado, Denver

Responsible Party: Hampar Karageozian, CEO
ClinicalTrials.gov Identifier: NCT00908778     History of Changes
Other Study ID Numbers: PVD- 302
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: October 20, 2009
Last Verified: October 2009

Keywords provided by Vitreoretinal Technologies, Inc.:
Diabetic Retinopathy

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