NCT00198471

Brief Summary

The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

September 13, 2005

Last Update Submit

March 13, 2013

Conditions

Vitreous DetachmentDiabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Vitreous detachment

    The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28

    Day 28

Study Arms (1)

Vitrase

EXPERIMENTAL

A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.

Drug: Vitrase

Interventions

VitraseDRUG
Also known as: ovine hyaluronidase
Vitrase

Eligibility Criteria

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

You may qualify if:

  • Moderately severe to severe non-proliferative diabetic retinopathy
  • Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) with pinhole of 20/320 or better in study eye \& 20/50 or better in non-study eye.

You may not qualify if:

  • Contraindications or hypersensitivities to Vitrase or anesthesia
  • Any significant illness that could be expected to interfere with trial
  • Prior Vitrase therapy
  • Either a past diagnosis of clinically significant macular edema (CME) in study eye that required treatment or current CME that may require focal laser treatment within the next 30 days
  • For either eye: ongoing ocular infection, inflammation or history of herpetic corneal lesion; an intravitreous injection within 30 days; glaucoma; intraocular pressure (IOP) of less than 5mmHg; retinal detachment or ocular tumors
  • For study eye: vascular occlusive disease of fundus; corneal, lenticular or ocular media abnormalities; a significant ocular trauma within 6 months; previous vitrectomy; any prior laser treatment, cryo-retinopexy or any intraocular surgery; either a partial or complete posterior vitreous detachment (PVD); myopia of 6 or more spherical diopters and/or axial length exceeding 26mm; significant retinal pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Edgar L. Thomas, MD

Beverly Hills, California, 90211, United States

Location

Ronni Lieberman, MD

New York, New York, 10021, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

The Virginia Retina Center

Leesburg, Virginia, 20176, United States

Location

MeSH Terms

Conditions

Vitreous DetachmentDiabetic Retinopathy

Interventions

Chondroitinases and Chondroitin Lyases

Condition Hierarchy (Ancestors)

Eye DiseasesRetinal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SulfatasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPolysaccharide-LyasesCarbon-Oxygen LyasesLyases

Study Officials

  • Jon Williams, PhD

    ISTA Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

July 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

US(4)