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

Diabetic Retinopathy Clinical Trial

Official title:

A Phase 3 Safety and Efficacy Study of Vitreosolve® for Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00908778
• Other study ID #: PVD- 302
• Status: Recruiting
• Phase: Phase 3
• First received: May 26, 2009
• Last updated: October 19, 2009
• Start date: October 2008

Study information

• Verified date: October 2009
• Source: Vitreoretinal Technologies, Inc.
• Contact: Philip N Calvillo
• Phone: 949-753-1008
• Email: Philip[@]vrtco.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Vitreosolve
intravitreal injection
• Vitreosolve
intravitreal injection

Locations

Country	Name	City	State
India	Amrita	Kochi
India	LVPEI	Vizag	AP
Mexico	Conde De Valenciana	Mexico City	DF
Mexico	Hidalgo	Monterrey	Neuvo Leon
Mexico	La Ceguera	San Lucas	Coyoacan

Sponsors (1)

Lead Sponsor	Collaborator
Vitreoretinal Technologies, Inc.

Countries where clinical trial is conducted

India,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound, OCT, and clinical exam		6 months	Yes
Secondary	Ultrasound ,OCT ,Safety, and Clinical Exam		6 months	Yes