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

A Phase 3 Safety and Efficacy Study of Vitreosolve® for Four Ophthalmic Intravitreal Injections For Inducing Posterior Vitreous Detachment in Retinopathy Patients.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00908778

Enrollment

160

Registered

2009-05-27

Start date

2008-10-31

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

50 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 or partial PVD at baseline exam in study eye.

Exclusion criteria

* Subjects with retinal pathology in the study eye other then (NPDR) * Subjects with high myopia in the study eye * Subjects who have monocular vision or central 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 then 6 months prior to study enrollment. * Subjects that have either vitrectomy surgery, intavitreal injections, or laser treatments in the study eye.

Design outcomes

Primary

Measure	Time frame
Ultrasound, OCT, and clinical exam	6 months

Secondary

Measure	Time frame
Ultrasound ,OCT ,Safety, and Clinical Exam	6 months

Countries

India, Mexico

Contacts

Primary ContactPhilip N Calvillo

Philip@vrtco.com949-753-1008

Outcome results

None listed

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