Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00644280
• Other study ID #: LinLucentis
• Secondary ID: NIH Grant # FVF4
• Status: Terminated
• Phase: N/A
• Start date: April 2008
• Est. completion date: January 2011

Study information

• Verified date: July 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Significant Ocular Adverse Events	Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment	6 months