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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Oftalmología Fundación Conde de Valenciana

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Council of Science and Technology, Mexico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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