Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Glaucoma

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00644280

LinLucentis

NIH Grant # FVF4191S

Details and patient eligibility

About

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.

Full 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)

Enrollment: 11 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Ranibizumab

Active Comparator group

Description:

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

Treatment:

Drug: Ranibizumab

Usual care

No Intervention group

Description:

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