Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

NCT ID: NCT01169909

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pterygium

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ranibizumab treatment

Patients will receive a sub-tenons injection of Ranibizumab 0.5mg, to be repeated twice with 30 day intervals between each dose.

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* History of CVA
* Monocular patients
* Minors
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Linda Rose

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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09-117

Identifier Type: -

Identifier Source: org_study_id

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