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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 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
History of Changes
  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
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 Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Ultrasound, OCT, and clinical exam [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ultrasound ,OCT ,Safety, and Clinical Exam [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hampar Karageozian, CEO
ClinicalTrials.gov Identifier: NCT00908778     History of Changes
Other Study ID Numbers: PVD- 302
Study First Received: May 26, 2009
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
Vitreous Detachment
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013