Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

July 11, 2022 updated by: University of California, San Francisco

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-0730
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ranibizumab
Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
Drug: Ranibizumab
intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections
Other Names:
  • Lucentis
No Intervention: Usual care
Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tube Success at 6 Months
Time Frame: 6 months
Criteria for success at 6 months postoperatively was intraocular pressure (IOP) < 18mmHg without the necessity for adjunctive medication for pressure or IOP < 15mmHg with <=1 adjunctive medication.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant Ocular Adverse Events
Time Frame: 6 months
Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Genentech, Inc.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LinLucentis
  • NIH Grant # FVF4191S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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