Treatment of Failing Blebs With Ranibizumab

NCT ID: NCT00570726

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2007-11-30

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.

Conditions

Glaucoma, Open-Angle; Failing Bleb Following Trabeculectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Ranibizumab (Lucentis)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

The New York Eye & Ear Infirmary

OTHER

Sponsor Role: lead

Principal Investigators

Jeffrey Liebmann, MD

Role: PRINCIPAL_INVESTIGATOR

Robert Ritch, MD, LLC.

Locations

Glaucoma Associates of New York

New York, New York, United States

Countries

United States

Other Identifiers

07.10

Identifier Type: -

Identifier Source: org_study_id