Treatment of Failing Blebs With Ranibizumab

NCT00570726 | Completed Phase 1

• 1 other identifier: 07.10
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Interventions

Ranibizumab (Lucentis) DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Glaucoma Associates of New York

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jeffrey Liebmann, MD

  Robert Ritch, MD, LLC.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2007
• First Posted: December 11, 2007
• Study Start: June 1, 2000
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: October 15, 2014

Record last verified: 2007-12

Locations

US (1)