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Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

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ClinicalTrials.gov Identifier: NCT01169909
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : May 17, 2016
Genentech, Inc.
Information provided by (Responsible Party):
Linda Rose, University of New Mexico

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

Condition or disease Intervention/treatment Phase
Pterygium Drug: Ranibizumab Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.
Study Start Date : August 2010
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. Regression of pterygium [ Time Frame: Within 30 days after drug injection ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • History of CVA
  • Monocular patients
  • Minors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169909

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.

Responsible Party: Linda Rose, Principal Investigator, University of New Mexico
ClinicalTrials.gov Identifier: NCT01169909     History of Changes
Other Study ID Numbers: 09-117
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by Linda Rose, University of New Mexico:

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents