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

• Sponsor: Vitreoretinal Technologies, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00664183
• Collaborator: (none)
• Enrollment: 400
• Locations: 17
• Arms: 2
• Patients Per Site: 23.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: Vitreosolve	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• 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 Ophthalmic Intravitreal Injection in Retinopathy Subjects
• Study Start Date: Mar 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Vitreosolve; Intravitreal injection
Experimental: 2	Drug: Vitreosolve; Intravitreal injection

Outcome Measures

Primary Outcome Measures

1. Ultrasound [7 Months]

Secondary Outcome Measures

1. Ultrasound, OCT, Safety [7 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Beverly Hills	California	United States
3		Santa Ana	California	United States
4		Gainesville	Florida	United States
5		Lakeland	Florida	United States
6		Indianapolis	Indiana	United States
7		New Albany	Indiana	United States
8		Asheville	North Carolina	United States
9		McAllen	Texas	United States
10		Silverdale	Washington	United States
11	LVPEI	Bhubhneshwar		India
12	Sankara Nethralaya	Chennai		India
13	Aravind	Coimbatore		India
14	AIIMS	Delhi		India
15	LVPEI	Hyderabad		India
16	Aravind	Madurai		India
17	Aravind	Pondicherry		India

Sponsors and Collaborators

• Vitreoretinal Technologies, Inc.

Investigators

• Principal Investigator: Baruch Kupperman, MD, University of California, Irvine
• Principal Investigator: Naresh Mandova, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00664183
• Other Study ID Numbers: PVD-301
• First Posted: Apr 22, 2008
• Last Update Posted: Oct 20, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: diabetic retinopathy
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy

Study Results

No Results Posted as of Oct 20, 2009