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Treatment of Failing Blebs With Ranibizumab

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00570726
First received: December 9, 2007
Last updated: October 14, 2014
Last verified: December 2007
  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: 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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00570726     History of Changes
Other Study ID Numbers: 07.10
Study First Received: December 9, 2007
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Eye Diseases
Glaucoma
Ocular Hypertension

ClinicalTrials.gov processed this record on November 23, 2014