Bevacizumab Injection for Recurrent Pterygium

Recurrent Pterygium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007174
• Other study ID #: CC-002-2011
• Status: Completed
• Phase: N/A
• First received: December 2, 2013
• Last updated: March 7, 2018
• Start date: March 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2018
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pterygium
• Recurrent Pterygium

Intervention

Drug:
• Bevacizumab

• 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.
• 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

Locations

Country	Name	City	State
Mexico	Institute of Ophthalmology, Conde de Valenciana Foundation	Mexico, City	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana	National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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. — View Citation

Nava-Castañeda 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptoms evaluation	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
Primary	Pterygium recurrence	Evidence of vessel growth on both, corneal and conjunctival area after bevacizumab treatment	One year
Secondary	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