A Safety and Efficacy Study of Vitreosolve® for Non-Proli... | NCT00908778

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

NCT00908778

Sponsor

Vitreoretinal Technologies, Inc.

Status

Unknown status

Last Update Posted

Oct 20, 2009Estimated

Enrollment

160Estimated

Phase

Phase 3

Conditions

Diabetic Retinopathy

Interventions

Vitreosolve
Vitreosolve

Countries

India
Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jul 2010Estimated

Completion Date

Not provided

First Submitted Date

May 26, 2009

First Submission Date that Met QC Criteria

May 26, 2009

First Posted Date

May 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2009

Last Update Posted Date

Oct 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitreosolve I	Experimental	Intravitreal injection	Drug: Vitreosolve
Vitreosolve	Experimental	Intravitreal injection	Drug: Vitreosolve

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitreosolve	Drug	intravitreal injection	Vitreosolve I
Vitreosolve

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ultrasound, OCT, and clinical exam		6 months

Secondary Outcomes

Measure	Description	Time Frame
Ultrasound ,OCT ,Safety, and Clinical Exam		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Philip N Calvillo	Contact	949-753-1008	120	Philip@vrtco.com

Overall Officials

Name	Affiliation	Role
Hugo Quiroz-Mercado, MD	APEC, Hospital La Ceguera	Principal Investigator
Naresh Mandova, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LVPEI	Recruiting	Vizag	Andhra Pradesh		India
Amrita

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided