Bevacizumab Injection for Recurrent Pterygium

March 7, 2018 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Mexico, City, Mexico City, Mexico, 06800
        • Institute of Ophthalmology, Conde de Valenciana Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bevacizumab injection
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
Other Names:
  • Avastin
Medical Treatment
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
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.
Argon Laser Treatment
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
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.
Procedure: Argon laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pterygium recurrence
Time Frame: One year
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
Time Frame: One year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms evaluation
Time Frame: One year
The frequency of symptoms (redness, watery eyes, itching, burning, foreign body sensation, and fluctuating vision) were evaluated according to Nava-Castañeda et al Questionnaire (2003). Symptoms were graded as follows: 0, never; 1, rarely (once a week); 2, occasionally (several times a week); 3, frequently (once a day); 4, usually (several times a day); and 5, continually (every hour of the day). In addition, the severity of these signs/sympots were scored at each visit on a scale of 0 to 3, with 0 representing the absence of the symptom, 1 mild, 2 moderate, and 3 severe. A total symptoms score, which is a measure of the overall severity of the patients,s conjunctival condition, was calculated by multiplying (for each individual symptom/condition) the numerical values corresponding to frequency and severity, and then adding the products for all symptoms.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Collaborators

National Council of Science and Technology, Mexico

Investigators

  • Principal Investigator: Angel Nava-Castañeda, MD, Msc, Institute of Ophthalmology, Conde de Valenciana Foundation
  • Study Director: Yonathan O Garfias, MD, PhD, Institute of Ophthalmology, Conde de Valenciana Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-002-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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