Ranibizumab for the Inhibition of Neovascularization in Pterygia

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

2008-10-31

Study Completion Date

2012-01-31

Brief Summary

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The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.

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Detailed Description

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As a secondary objective, this study also aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection in patients undergoing pterygium excision and to determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.

Conditions

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Pterygium

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients will receive one injection of ranibizumab 3 days prior to surgery

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

0.5 mg subconjunctival ranibizumab 3 days prior to surgery

2

Patients will undergo one injection of ranibizumab at the time of surgery

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

0.5 mg subconjunctival ranibizumab at the time of surgery

Interventions

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ranibizumab

0.5 mg subconjunctival ranibizumab 3 days prior to surgery

Intervention Type DRUG

ranibizumab

0.5 mg subconjunctival ranibizumab at the time of surgery

Intervention Type DRUG

Other Intervention Names

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Lucentis Lucentis

Eligibility Criteria

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Inclusion Criteria

* Subjects will be eligible if the following criteria are met:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Patient related considerations: All patients of both genders will be considered for enrollment.
* Disease related considerations:

* Patients with pterygia will be considered for enrollment if the pterygium meets standard pterygium excision criteria including encroachment into the visual axis
* severe induced astigmatism
* foreign body sensation unresponsive to medical therapy.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from this study:

* Pregnancy (positive pregnancy test)
* Women seeking to become pregnant
* Lactating women
* Prior enrollment in the study
* Prior glaucoma surgery in the region of the pterygium
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No