Ranibizumab for the Inhibition of Neovascularization in Pterygia

Study Overview
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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.

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.

Official Title
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Ranibizumab for the Inhibition of Neovascularization in Pterygia

Conditions
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Pterygium

Intervention / Treatment
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* Drug: ranibizumab
* Drug: ranibizumab


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients will receive one injection of ranibizumab 3 days prior to surgery | Drug: ranibizumab<br>* 0.5 mg subconjunctival ranibizumab 3 days prior to surgery<br>* Other names: Lucentis;|
| Experimental: 2<br>Patients will undergo one injection of ranibizumab at the time of surgery | Drug: ranibizumab<br>* 0.5 mg subconjunctival ranibizumab at the time of surgery<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection and determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ranibizumab, pterygium