Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Failing Blebs With Ranibizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00570726
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : October 15, 2014
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
The New York Eye & Ear Infirmary

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study was designed to evaluate the efficacy and safety in the use of Ranibizumab, an effective vascular endothelial growth factor (VGEF) inhibitor, in treating patients with a failing bleb, characterized by increased fibrosis and vascularization of the conjuctiva, following trabeculectomy. Six subjects from one site will be enrolled in this study.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Failing Bleb Following Trabeculectomy Drug: Ranibizumab (Lucentis) Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Needle Bleb Revision With Ranibizumab as a Primary Intervention in a Failing Bleb Following Trabeculectomy
Study Start Date : June 2000
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Ranibizumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 40 years
  • Patients with Open-angle Glaucoma who have had trabeculectomy
  • Patients determined to have failing bleb with presence of superficial bleb vascularity and IOP increase on 3 successive visits without topical medication
  • Patients whose intraocular pressure (IOP) is above goal IOP after suture lysis and digital compression have been attempted

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or lactation.
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Current infection or inflammation in either eye
  • Any abnormality preventing reliable applanation tonometry in either eye
  • Other non-glaucomatous disease affecting visual field, (pituitary lesions, demyelinating disease, congenital optic nerve anomaly, prior retinal and optic nerve vascular occlusive disease, retinal dystrophy and degeneration, diabetes and HIV and AIDS infection)
  • Strabismus, nystagmus, monocular patient
  • Prior enrollment in the study
  • Any other condition that 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570726


Locations
Layout table for location information
United States, New York
Glaucoma Associates of New York
New York, New York, United States, 10003
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Genentech, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey Liebmann, MD Robert Ritch, MD, LLC.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00570726    
Other Study ID Numbers: 07.10
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: December 2007
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents