Failing Bleb Following Trabeculectomy, Glaucoma, Open-Angle
Conditions
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.
Interventions
Sponsors
Genentech, Inc.
The New York Eye & Ear Infirmary
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Countries
United States
Outcome results
None listed