Skip to main content
OpenTrials
Completed

NCT Number: NCT00570726

Treatment of Failing Blebs With Ranibizumab

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glaucoma Associates of New York

New York, 10003, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab (Lucentis)

Drug

Sponsors and collaborators

Lead sponsor

The New York Eye & Ear Infirmary

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Dec 11, 2007
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.