Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ranibizumab

Intervention Type DRUG

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

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ranibizumab

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

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No