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 Ophthalmic Intravitreal Injection in Retinopathy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00664183
• Other study ID #: PVD-301
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 18, 2008
• Last updated: October 19, 2009
• Start date: March 2008

Study information

• Verified date: October 2009
• Source: Vitreoretinal Technologies, Inc.
• Contact: n/a
• 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: Terminated
• Enrollment: 400
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 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 PVD at baseline exam in the study eye.

Exclusion Criteria:

• Subjects with Retinal pathology in the study eye other than (NPDR)

• Subjects with high myopia in the study eye

• Subjects who have monocular vision or contra 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 than 6 months prior to study enrollment

• Subjects that have had either vitrectomy surgery, intravitreal 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

Locations

Country	Name	City	State
India	LVPEI	Bhubhneshwar
India	Sankara Nethralaya	Chennai
India	Aravind	Coimbatore
India	AIIMS	Delhi
India	LVPEI	Hyderabad
India	Aravind	Madurai
India	Aravind	Pondicherry

Sponsors (1)

Lead Sponsor	Collaborator
Vitreoretinal Technologies, Inc.

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound		7 Months	Yes
Secondary	Ultrasound, OCT, Safety		7 Months	Yes