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Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

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

Tracking Information
First Submitted Date  ICMJE March 24, 2008
First Posted Date  ICMJE March 26, 2008
Results First Submitted Date  ICMJE May 29, 2013
Results First Posted Date  ICMJE July 26, 2013
Last Update Posted Date July 31, 2013
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
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 ]
Change History Complete list of historical versions of study NCT00644280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2013)
Significant Ocular Adverse Events [ Time Frame: 6 months ]
Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2008)
Ocular adverse events at 6 months including endopthalmitis, rhegmatogenous retinal detachment [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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  ICMJE
  • 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
    Intervention: Drug: Ranibizumab
  • No Intervention: Usual care
    Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Publications * Desai RU, Singh K, Lin SC. Intravitreal ranibizumab as an adjunct for Ahmed valve surgery in open-angle glaucoma: a pilot study. Clin Exp Ophthalmol. 2013 Mar;41(2):155-8. doi: 10.1111/j.1442-9071.2012.02836.x. Epub 2012 Sep 4.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 25, 2013)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2008)
30
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644280
Other Study ID Numbers  ICMJE LinLucentis
NIH Grant # FVF4191S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shan Lin, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Genentech, Inc.
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
PRS Account University of California, San Francisco
Verification Date July 2013

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