Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

This study has been terminated.
(low recruitment)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Shan Lin, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00644280
First received: March 24, 2008
Last updated: July 25, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of California, San Francisco:

Primary Outcome Measures:
  • Tube Success at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Study First Received: March 24, 2008
Results First Received: May 29, 2013
Last Updated: July 25, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 01, 2014