Bevacizumab Injection for Recurrent Pterygium

NCT02007174 | Completed DMC

• 1 other identifier: CC-002-2011
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Pterygium

Keywords

recurrent pterygium; bevacizumab; triple dose

Outcome Measures

Primary Outcomes (1)

• Pterygium recurrence

  Evidence of vessel growth on both, corneal and conjunctival area after bevacizumab treatment

  One year

Secondary Outcomes (1)

• Pterygia measurements

  One year

Other Outcomes (1)

• Symptoms evaluation

  One year

Study Arms (3)

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

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

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; Procedure: Argon laser treatment

Interventions

Bevacizumab DRUG

Also known as: Avastin

Bevacizumab injection

Medical Treatment DRUG

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.

Medical Treatment

Argon laser treatment PROCEDURE

Argon Laser Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women. Patients with diabetes Mellitus and colagenopathies.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Institute of Ophthalmology, Conde de Valenciana Foundation

Mexico City, Mexico City, 06800, Mexico

Location

Related Publications (3)

• Welch MN, Reilly CD, Kalwerisky K, Johnson A, Waller SG. Pterygia measurements are more accurate with anterior segment optical coherence tomography - a pilot study. Nepal J Ophthalmol. 2011 Jan-Jun;3(1):9-12. doi: 10.3126/nepjoph.v3i1.4271.

  PMID: 21505540 BACKGROUND

• Nava-Castaneda A, Tovilla-Canales JL, Rodriguez L, Tovilla Y Pomar JL, Jones CE. Effects of lacrimal occlusion with collagen and silicone plugs on patients with conjunctivitis associated with dry eye. Cornea. 2003 Jan;22(1):10-4. doi: 10.1097/00003226-200301000-00003.

  PMID: 12502940 BACKGROUND

• Nava-Castaneda A, Ulloa-Orozco I, Garnica-Hayashi L, Hernandez-Orgaz J, Jimenez-Martinez MC, Garfias Y. Triple subconjunctival bevacizumab injection for early corneal recurrent pterygium: one-year follow-up. J Ocul Pharmacol Ther. 2015 Mar;31(2):106-13. doi: 10.1089/jop.2014.0060. Epub 2014 Nov 4.

  PMID: 25369364 BACKGROUND

MeSH Terms

Conditions

Pterygium

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Angel Nava-Castañeda, MD, Msc

  Institute of Ophthalmology, Conde de Valenciana Foundation

  PRINCIPAL INVESTIGATOR

• Yonathan O Garfias, MD, PhD

  Institute of Ophthalmology, Conde de Valenciana Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 10, 2013
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

ME (1)