Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

Pterygium Clinical Trial

Official title:

The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01169909
• Other study ID #: 09-117
• Status: Recruiting
• Phase: Phase 1
• First received: July 23, 2010
• Last updated: November 9, 2011
• Start date: August 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2011
• Source: University of New Mexico
• Contact: Linda Rose, MD
• Phone: 505-272-6120
• Email: lirose[@]salud.unm.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.

Description:

Ptergyia are chronic fibrovascular lesions of the ocular surface. This study is designed to look for a signal of efficacy when the lesions are in a phase of active vascular growth. This phase is most often caught in a newly recurring pterygia post-operatively.

Patients identified with actively growing lesions, will be offered local injections directly beneath the lesions. They will be examined for any adverse side effects and regression of the lesion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.

Exclusion Criteria:

• Pregnancy

• History of CVA

• Monocular patients

• Minors

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

Drug:
• Ranibizumab
Subtenon injections of Ranibizumab 0.5mg will be given, and repeated twice with 30 day intervals between each dose. Note, after an amendment in February 2011, this dose was increased to 2mg with the same schedule.

Locations

Country	Name	City	State
United States	University of New Mexico Health Science Center	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	The following safety criteria will be monitored: subjective complaints, objective signs of inflammation, intraocular pressure, tear film and ocular surface integrity.	Within the first 30 days after injection	Yes
Secondary	Regression of pterygium	Regression of the lesion will be determined by measurement if the horizontal extension of the lesion relative to the limbus, and by photographic comparison incorporating software analysis	Within 30 days after drug injection	No