Treatment of Failing Blebs With Ranibizumab

The New York Eye & Ear Infirmary

Status and phase

Completed

Phase 1

Conditions

Failing Bleb Following Trabeculectomy

Glaucoma, Open-Angle

Treatments

Drug: Ranibizumab (Lucentis)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00570726

07.10

Details and patient eligibility

About

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.

Enrollment

6 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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