NCT00908778

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

October 20, 2009

Status Verified

October 1, 2009

Enrollment Period

1.7 years

First QC Date

May 26, 2009

Last Update Submit

October 19, 2009

Conditions

Diabetic Retinopathy

Keywords

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Ultrasound, OCT, and clinical exam

    6 months

Secondary Outcomes (1)

  • Ultrasound ,OCT ,Safety, and Clinical Exam

    6 months

Study Arms (2)

Vitreosolve I

EXPERIMENTAL

Intravitreal injection

Drug: Vitreosolve

Vitreosolve

EXPERIMENTAL

Intravitreal injection

Drug: Vitreosolve

Interventions

VitreosolveDRUG

intravitreal injection

Vitreosolve I

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 or partial PVD at baseline exam in study eye.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

LVPEI

Vizag, Andhra Pradesh, India

RECRUITING

Amrita

Kochi, India

RECRUITING

La Ceguera

San Lucas, Coyoacan, Mexico

RECRUITING

Conde De Valenciana

Mexico City, Mexico City, Mexico

RECRUITING

Hidalgo

Monterrey, Neuvo Leon, Mexico

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Hugo Quiroz-Mercado, MD

    APEC, Hospital La Ceguera

    PRINCIPAL INVESTIGATOR

  • Naresh Mandova, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip N Calvillo

CONTACT

949-753-1008Philip@vrtco.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2010

Last Updated

October 20, 2009

Record last verified: 2009-10

Locations

ME(3)IN(2)