Bevacizumab Injection for Recurrent Pterygium

Study Overview
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Brief Summary
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Blockade of vascular endothelial growth factor (VEGF) with bevacizumab has been used to treat abnormal vascular conditions of the anterior segment of the eye. In pterygium, anti-VEGF agents have been recently proposed as primary treatments, such as perioperative adjuvants, as well as treatments for pterygia recurrences after surgery. The aim of the present study was to prospectively evaluate the effect of three subconjunctival bevacizumab injections in patients with an early pterygium recurrence. Materials and Methods: The current study was a non-randomized single central trial. The method of ensuring allocation concealment was sequentially numbered. Patients with an early pterygium recurrence were selected and invited to participate in the study. Recurrence was defined as the presence of corneal vessels with concomitant conjunctival hyperemia within the first trimester after primary pterygium removal, and only patients with primary pterygium recurrence were included. Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women were excluded from the study. All patients received three subconjunctival bevacizumab (2.5 mg/0.05 ml) injections (basal, 2 and 4 weeks) in the recurrence area of the pterygium, and were photographed at the third, sixth and twelfth months after the last bevacizumab injection. Photographic analyses were performed taking into account two pterygium areas: the first measure included only the vessel area in the corneal surface, while the second measure included, both, conjunctival and corneal vessel area (corneal-conjunctival area of hyperemia). Neovascularization area of each pterygium was determined using digital slit lam pictures, which were analyzed using Photoshop CS4, in order to get pixels measurements of the lesion.

Detailed Description
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The method of ensuring allocation concealment was sequentially numbered. Patients with an early pterygium recurrence were selected and invited to participate in the study. Recurrence was defined as the presence of corneal vessels with concomitant conjunctival hyperemia within the first trimester after primary pterygium removal, and only patients with primary pterygium recurrence were included. Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women were excluded from the study. All patients received three subconjunctival bevacizumab (2.5 mg/0.05 ml) injections (basal, 2 and 4 weeks) in the recurrence area of the pterygium, and were photographed at the third, sixth and twelfth months after the last bevacizumab injection. Photographic analyses were performed taking into account two pterygium areas: the first measure included only the vessel area in the corneal surface, while the second measure included, both, conjunctival and corneal vessel area (corneal-conjunctival area of hyperemia). Neovascularization area of each pterygium was determined using digital slit lam pictures, which were analyzed using Photoshop CS4, in order to get pixels measurements of the lesion.

Official Title
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Triple Subconjunctival Bevacizumab Injection for Early Recurrent Pterygium. One Year Follow-up

Conditions
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Recurrent Pterygium

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Medical Treatment
* Drug: Medical Treatment
* Procedure: Argon laser treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an early pterygium recurrence were selected and invited to participate in the study. Recurrence was defined as the presence of corneal vessels with concomitant conjunctival hyperemia within the first trimester after primary pterygium removal, and only patients with primary pterygium recurrence were included Exclusion Criteria: Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women. Patients with diabetes Mellitus and colagenopathies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bevacizumab injection<br>Three subconjunctival intralesional injections of bevacizumab. Bevacizumab injections were 2.5 mg/0.05 ml, subconjunctivally applied near to the pterygium recurrence. Application of bevacizumab was performed three times: basal, 2 and 4 weeks. | Drug: Bevacizumab<br> <br> * Other names: Avastin;|
| Medical Treatment<br>In order to reduce the patient bias, the control eye received a sham laser treatment, under slit lamp, topical anesthesia using 0.5% tetracaine hydrochloride eye drops (Ponti-Ofteno, Laboratorios Sophia, Jalisco, Mexico) and topical 1 mg fluorescein Sodium staining (Bio-Glo, Hub Pharmaceuticals, Rancho Cucamonga CA). Post sham laser care treatment included topical eyedrops of 0.3% tobramycin and 0.1% dexamethasone (Trazidex, Laboratorios Sophia) three times daily, and 0.5 carboxymethylcellulose lubricating eye drops (Refresh-Tears, Allergan, Irving, California, USA). Topical antibiotics and corticosteroids were tapered and discontinued after two weeks. | Drug: Medical Treatment<br>* Care treatment included topical eyedrops of 0.3% tobramycin and 0.1% dexamethasone (Trazidex, Laboratorios Sophia) three times daily, and 0.5 carboxymethylcellulose lubricating eye drops (Refresh-Tears, Allergan, Irving, California, USA). Topical antibiotics and corticosteroids were tapered and discontinued after two weeks.<br>|
| Argon Laser Treatment<br>Argon laser therapies were performed on an outpatient basis only by one ophthalmologist. Under slit lamp, topical anesthesia using 0.5% tetracaine hydrochloride eye drops (Ponti-Ofteno, Laboratorios Sophia, Jalisco, Mex) and topical 1 mg fluorescein Sodium staining (Bio-Glo, Hub Pharmaceuticals, Rancho Cucamonga CA) was applied. Argon laser was applied along the vessels of the pterygium apex with power between 450mW to 780 mW, spot size of 100 u with 10 milliseconds duration. Additional grill pattern treatment was given to pterygium body using a 200 microns spot size. Treatments were given in one only session. Post laser care treatment included topical eyedrops of 0.3% tobramycin and 0.1% dexamethasone (Trazidex, Laboratorios Sophia) three times daily, and 0.5 carboxymethylcellulose lubricating eye drops (Refresh-Tears, Allergan, Irving, CA, USA). Topical antibiotics and corticosteroids were tapered and discontinued after two weeks. | Drug: Medical Treatment<br>* Care treatment included topical eyedrops of 0.3% tobramycin and 0.1% dexamethasone (Trazidex, Laboratorios Sophia) three times daily, and 0.5 carboxymethylcellulose lubricating eye drops (Refresh-Tears, Allergan, Irving, California, USA). Topical antibiotics and corticosteroids were tapered and discontinued after two weeks.<br>Procedure: Argon laser treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pterygium recurrence | Evidence of vessel growth on both, corneal and conjunctival area after bevacizumab treatment | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pterygia measurements | Measurements were performed according to Welch et al. modified technique as following: the distance in millimeters from the limbus to the apex of the lesion on the cornea (horizontal length) was performed using the slit-lamp beam (BQ 900, Haag-Streit, Koeniz, Switzerland). A standard magnification of 16 was used and the variable aperture was focused from the limbus to the apex. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pterygium, bevacizumab, triple dose