Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

March 24, 2008

Last Updated Date

July 6, 2011

Start Date ^ICMJE

April 2008

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome measure is % of subjects with a tube success at 6 months (IOP of < 22mmHg and no adjunctive meds for pressure) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00644280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Ocular adverse events at 6 months including endophthalmitis, rhegmatogenous retinal detachment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Ocular adverse events at 6 months including endopthalmitis, rhegmatogenous retinal detachment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

Official Title ^ICMJE

Evaluation of Safety and Efficacy of Ranibizumab in Glaucoma Patients Treated With Filtration Tubes"

Brief Summary

To determine whether ranibizumab therapy before and after tube insertion for glaucoma surgeries can maintain the patency of the tube and prevent scar formation, and increase the chances for a successful procedure compared to observation.

Detailed Description

This is a randomized, open-label, Phase I/II study of intravitreally administered ranibizumab for the treatment of tube patency in glaucoma patients.

Thirty (30) patients with severe glaucoma requiring tubes will be randomized (2:1) to either ranibizumab or observation.

Consented, enrolled subjects assigned to the treatment group will receive open-label intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections Sham intravitreal injections for the observation group will NOT be performed.

Study periods:

Study start date: May 1st, 2007 (estimated) Enrollment period: 6-8 months (estimated) Follow-up period: 6 months Study end Date: December 1st, 2010 (estimated)

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

Drug: Ranibizumab

intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections

Other Name: Lucentis

Study Arms

Active Comparator: 1
Injection of Ranibizumab pre and post operative.

Intervention: Drug: Ranibizumab
No Intervention: 2
Standard of care without injections of Ranibizumab

Publications *

* 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

Estimated Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

ability to provide written informed consent and comply with study assessment for the full duration of the study.
age ≥ 21
diagnosis of glaucoma and determined to be candidate for therapy with tube insertion.

Exclusion Criteria:

pregnant or lactating females
Persons on oral contraceptives and women of child-bearing age
prior enrollment in the study
any conditions the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
participation in another simultaneous medical investigation or trial
history of active inflammatory, infectious, or idiopathic keratitis precluding view of anterior segment structures
previous injections of ranibizumab in either eye.
Persons on Plavix (clopidogrel bisulfate) and coumadin
Persons with uncontrolled high blood pressure
Persons with renal or liver disease

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00644280

Other Study ID Numbers ^ICMJE

LinLucentis, NIH Grant # FVF4191S

Has Data Monitoring Committee

Yes

Responsible Party

Shan Lin, University of California, San Francisco

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Genentech

Investigators ^ICMJE

Study Chair:	Robert Bhisitkul, M.D. , Ph.D.	University of California, San Francisco
Study Chair:	Rajen U Desai	Stanford University
Study Director:	Patricia Tam	University of California, San Francisco

Information Provided By

University of California, San Francisco

Verification Date

July 2011

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