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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00664183
Other study ID # PVD-301
Secondary ID
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. completion date
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


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
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