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

A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00664183

Enrollment

400

Registered

2008-04-22

Start date

2008-03-31

Completion date

Unknown

Last updated

2009-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy

Brief summary

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

Interventions

DRUGVitreosolve

Intravitreal injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Ultrasound	7 Months

Secondary

Measure	Time frame
Ultrasound, OCT, Safety	7 Months

Countries

India, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026