Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

NCT00644280 | Terminated Results DMC

• 2 other identifiers: LinLucentisNIH Grant # FVF4191S
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Glaucoma,Ahmed Valve

Outcome Measures

Primary Outcomes (1)

• Tube Success at 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 Outcomes (1)

• Significant Ocular Adverse Events

  6 months

Study Arms (2)

Ranibizumab

ACTIVE COMPARATOR

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

Usual care

NO INTERVENTION

Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab

Interventions

Ranibizumab DRUG

intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to provide written informed consent and comply with study assessment for the full duration of the study.
• age ≥ 21
• diagnosis of glaucoma and determined to be candidate for therapy with tube insertion.

You may not qualify if:

• pregnant or lactating females
• Persons on oral contraceptives and women of child-bearing age
• prior enrollment in the study
• any conditions the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• participation in another simultaneous medical investigation or trial
• history of active inflammatory, infectious, or idiopathic keratitis precluding view of anterior segment structures
• previous injections of ranibizumab in either eye.
• Persons on Plavix (clopidogrel bisulfate) and coumadin
• Persons with uncontrolled high blood pressure
• Persons with renal or liver disease

Sponsors & Collaborators

• University of California, San Francisco: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0730, United States

Location

Related Publications (1)

• 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.

  PMID: 22712537 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

IOP reduction may be attributable to cataract surgery instead of or in addition to ranibizumab use. Further studies, with larger sample size and longer follow-up, are needed to evaluate safety and potential efficacy of intravitreal ranibizumab.

Results Point of Contact

• Title: Shan C. Lin, MD
• Organization: University of California San Francisco

lins@vision.ucsf.edu

415-353-2608

Study Officials

• Robert Bhisitkul, M.D., Ph.D.

  University of California, San Francisco

  STUDY CHAIR

• Rajen U Desai

  Stanford University

  STUDY CHAIR

• Patricia Tam

  University of California, San Francisco

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 2, 2022
• Results First Posted: July 26, 2013

Record last verified: 2022-07

Locations

US (1)