Treatment of Failing Blebs With Ranibizumab

Phase 1

Completed

• Conditions: Glaucoma, Open-Angle; Failing Bleb Following Trabeculectomy

• Registration Number: NCT00570726
• Lead Sponsor: The New York Eye & Ear Infirmary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2007-12
• Study First Submitted: 2007-12-09
• Study First Submitted QC: 2007-12-09
• Study First Posted: 2007-12-11
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Glaucoma Associates of New York; 🇺🇸 New York, New York, United States