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Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

Primary Purpose

Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma,Ahmed Valve

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Ranibizumab

Usual care

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Significant Ocular Adverse Events
Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment

Full Information

First Posted
March 24, 2008
Last Updated
July 11, 2022
Sponsor
University of California, San Francisco
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00644280
Brief Title
Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery
Official Title
Evaluation of Safety and Efficacy of Ranibizumab in Glaucoma Patients Treated With Filtration Tubes"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
low recruitment
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma,Ahmed Valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm 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
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
intravitreal injection of 0.5 mg ranibizumab 1 week prior to tube insertion and then monthly x 2 more injections
Primary Outcome Measure Information:
Title
Tube Success at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Significant Ocular Adverse Events
Description
Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Bhisitkul, M.D., Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rajen U Desai
Organizational Affiliation
Stanford University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patricia Tam
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0730
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22712537
Citation
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.
Results Reference
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Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

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