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Completed

NCT Number: NCT01169909

Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

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

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • History of CVA
  • Monocular patients
  • Minors

Treatment and study plan

ranibizumab

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 26, 2010
Registry last updated
May 17, 2016

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.

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