Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Linda Rose, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01169909
First received: July 23, 2010
Last updated: May 13, 2016
Last verified: May 2016
  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


Enrollment: 10
Study Start Date: August 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01169909

Locations
United States, New Mexico
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
University of New Mexico
Genentech, Inc.
  More Information

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: May 13, 2016
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
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 29, 2016