Expired Study
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New York, New York 10003


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

07.10


NCT ID:

NCT00570726


Secondary ID:


Study Acronym:


Brief Title:

Treatment of Failing Blebs With Ranibizumab


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The New York Eye & Ear Infirmary


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model: Si


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

6


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jeffrey Liebmann, MD
Principal Investigator
Glaucoma Associates of New York

Study Dates

Start Date:June 2000
Completion Date:November 2007
Completion Type:Actual
Primary Completion Date:November 2007
Primary Completion Type:Actual
Verification Date:December 2007
Last Changed Date:October 14, 2014
First Received Date:December 9, 2007

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Ranibizumab (Lucentis)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The New York Eye & Ear Infirmary
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Genentech, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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