Treatment of Failing Blebs With Ranibizumab

Glaucoma, Open-Angle Clinical Trial

Official title:

Effect of Needle Bleb Revision With Ranibizumab as a Primary Intervention in a Failing Bleb Following Trabeculectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570726
• Other study ID #: 07.10
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2007
• Last updated: October 14, 2014
• Start date: June 2000
• Est. completion date: November 2007

Study information

• Verified date: December 2007
• Source: The New York Eye & Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failing Bleb Following Trabeculectomy
• Glaucoma, Open-Angle

Intervention

Drug:
• Ranibizumab (Lucentis)

Locations

Country	Name	City	State
United States	Glaucoma Associates of New York	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The New York Eye & Ear Infirmary	Genentech, Inc.

Country where clinical trial is conducted

United States,