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Treatment of Failing Blebs With Ranibizumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00570726
First Posted: December 11, 2007
Last Update Posted: October 15, 2014
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.
Collaborator:
Genentech, Inc.
Information provided by:
The New York Eye & Ear Infirmary
  Purpose
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 Intervention Phase
Glaucoma, Open-Angle Failing Bleb Following Trabeculectomy Drug: Ranibizumab (Lucentis) Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The New York Eye & Ear Infirmary:

Estimated Enrollment: 6
Study Start Date: June 2000
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
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
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
Principal Investigator: Jeffrey Liebmann, MD Glaucoma Associates of New York
  More Information

ClinicalTrials.gov Identifier: NCT00570726     History of Changes
Other Study ID Numbers: 07.10
First Submitted: December 9, 2007
First Posted: December 11, 2007
Last Update Posted: October 15, 2014
Last Verified: December 2007

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents