Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of New Mexico.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Linda Rose, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01169909
First received: July 23, 2010
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Pterygium
Drug: Ranibizumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Safety [ Time Frame: Within the first 30 days after injection ] [ Designated as safety issue: Yes ]
    The following safety criteria will be monitored: subjective complaints, objective signs of inflammation, intraocular pressure, tear film and ocular surface integrity.


Secondary Outcome Measures:
  • Regression of pterygium [ Time Frame: Within 30 days after drug injection ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 10
Study Start Date: August 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab treatment
Patients will receive a sub-tenons injection of Ranibizumab 0.5mg, to be repeated twice with 30 day intervals between each dose.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • History of CVA
  • Monocular patients
  • Minors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169909

Contacts
Contact: Linda Rose, MD 505-272-6120 lirose@salud.unm.edu
Contact: Arup Das, MD 505-272-6123 adas@salud.unm.edu

Locations
United States, New Mexico
University of New Mexico Health Science Center Recruiting
Albuquerque, New Mexico, United States, 87106
Principal Investigator: Linda Rose, MD PhD         
Sponsors and Collaborators
University of New Mexico
Genentech
  More Information

No publications provided

Responsible Party: Linda Rose, Principal Investigator, University of New Mexico
ClinicalTrials.gov Identifier: NCT01169909     History of Changes
Other Study ID Numbers: 09-117
Study First Received: July 23, 2010
Last Updated: November 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of New Mexico:
Pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 22, 2014