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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Vitreoretinal Technologies, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00908778
First Posted: May 27, 2009
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.
  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 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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

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

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

Estimated Enrollment: 160
Study Start Date: October 2008
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitreosolve I
Intravitreal injection
Drug: Vitreosolve
intravitreal injection
Experimental: Vitreosolve
Intravitreal injection
Drug: Vitreosolve
intravitreal injection

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
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


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

Locations
India
LVPEI Recruiting
Vizag, AP, India
Amrita Recruiting
Kochi, India
Mexico
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.
Investigators
Principal Investigator: Hugo Quiroz-Mercado, MD APEC, Hospital La Ceguera
Principal Investigator: Naresh Mandova, MD University of Colorado, Denver
  More Information

Responsible Party: Hampar Karageozian, CEO
ClinicalTrials.gov Identifier: NCT00908778     History of Changes
Other Study ID Numbers: PVD- 302
First Submitted: May 26, 2009
First Posted: May 27, 2009
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