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Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00198471
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date March 15, 2013
Study Start Date  ICMJE July 2005
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2013)
Vitreous detachment [ Time Frame: Day 28 ]
The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Primary efficacy endpoint will be the proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28
Change History Complete list of historical versions of study NCT00198471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment
Official Title  ICMJE An Open-label Assessment of Intravitreous Injections of Vitrase (Hyaluronidase for Injection) for Inducing Posterior Vitreous Detachment in Subjects With Moderate to Severe Non-proliferative Diabetic Retinopathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitreous Detachment
  • Diabetic Retinopathy
Intervention  ICMJE Drug: Vitrase
Other Name: ovine hyaluronidase
Study Arms  ICMJE Experimental: Vitrase
A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1.
Intervention: Drug: Vitrase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
10
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00198471
Other Study ID Numbers  ICMJE ISTA-VIT-CS07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jon Williams, PhD ISTA Pharmaceuticals, Inc.
PRS Account Bausch & Lomb Incorporated
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP