This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Information provided by:
Vitreoretinal Technologies, Inc. Identifier:
First received: May 26, 2009
Last updated: October 19, 2009
Last verified: October 2009
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


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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00908778

Contact: Philip N Calvillo 949-753-1008 ext 120

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
  More Information

Responsible Party: Hampar Karageozian, CEO Identifier: NCT00908778     History of Changes
Other Study ID Numbers: PVD- 302
Study First Received: May 26, 2009
Last Updated: October 19, 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 processed this record on August 17, 2017