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

Stopped early · Phase 2/Phase 3

Conditions studied: Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT00664183

Run by

Vitreoretinal Technologies, Inc.

People needed

400

Starts

2008-03-01

Last updated by the study team

2009-10-20

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Santa Ana, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New Albany, Indiana, United States
• Study site — Asheville, North Carolina, United States
• Study site — McAllen, Texas, United States
• Study site — Silverdale, Washington, United States
• LVPEI — Bhubhneshwar, India
• Sankara Nethralaya — Chennai, India
• Aravind — Coimbatore, India
• AIIMS — Delhi, India
• LVPEI — Hyderabad, India
• Aravind — Madurai, India
• Aravind — Puducherry, India

Full record on ClinicalTrials.gov

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