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Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

This study has been terminated.
(low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644280
First Posted: March 26, 2008
Last Update Posted: July 31, 2013
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Shan Lin, University of California, San Francisco
  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.

Condition Intervention
Glaucoma Drug: Ranibizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Ranibizumab in Glaucoma Patients Treated With Filtration Tubes"

Resource links provided by NLM:


Further study details as provided by Shan Lin, University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Significant Ocular Adverse Events [ Time Frame: 6 months ]
    Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment


Enrollment: 11
Study Start Date: April 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lucentis
No Intervention: Usual care
Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab

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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644280


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0730
Sponsors and Collaborators
University of California, San Francisco
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
  More Information

Publications:
Responsible Party: Shan Lin, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00644280     History of Changes
Other Study ID Numbers: LinLucentis
NIH Grant # FVF4191S
First Submitted: March 24, 2008
First Posted: March 26, 2008
Results First Submitted: May 29, 2013
Results First Posted: July 26, 2013
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by Shan Lin, University of California, San Francisco:
Glaucoma,Ahmed Valve

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents


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