Expired Study
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San Francisco, California 94143


Purpose:

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.


Study summary:

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)


Criteria:

Inclusion Criteria: 1. ability to provide written informed consent and comply with study assessment for the full duration of the study. 2. age ≥ 21 3. diagnosis of glaucoma and determined to be candidate for therapy with tube insertion. Exclusion Criteria: 1. pregnant or lactating females 2. Persons on oral contraceptives and women of child-bearing age 3. prior enrollment in the study 4. any conditions the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated 5. participation in another simultaneous medical investigation or trial 6. history of active inflammatory, infectious, or idiopathic keratitis precluding view of anterior segment structures 7. previous injections of ranibizumab in either eye. 8. Persons on Plavix (clopidogrel bisulfate) and coumadin 9. Persons with uncontrolled high blood pressure 10. Persons with renal or liver disease


Study is Available At:


Original ID:

LinLucentis


NCT ID:

NCT00644280


Secondary ID:

NIH Grant # FVF4191S


Study Acronym:


Brief Title:

Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert Bhisitkul, M.D. , Ph.D.
Study Chair
University of California, San Francisco

Study Dates

Start Date:April 2008
Completion Date:January 2011
Completion Type:Actual
Primary Completion Date:December 2010
Primary Completion Type:Actual
Verification Date:November 2012
Last Changed Date:November 14, 2012
First Received Date:March 24, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Ocular adverse events at 6 months including endophthalmitis, rhegmatogenous retinal detachment
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ranibizumab
Description:intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections
Arm Name:1
Other Name:Lucentis

Study Arms

Study Arm Type:No Intervention
Arm Name:2
Description:Standard of care without injections of Ranibizumab
Study Arm Type:Active Comparator
Arm Name:1
Description:Injection of Ranibizumab pre and post operative.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Genentech

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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