Clinical trial NCT02007174: Bevacizumab Injection for Recurrent Pterygium
Official title: Triple Subconjunctival Bevacizumab Injection for Early Recurrent Pterygium. One Year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Pterygium
Keywords: recurrent pterygium
bevacizumab
triple dose
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2013-12-10
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pterygium recurrence
timeFrame: One year
Secondary outcomes:
measure: Pterygia measurements
timeFrame: One year
Other outcomes:
measure: Symptoms evaluation
timeFrame: One year
Locations:
city: Mexico, City
country: Mexico
facility: Institute of Ophthalmology, Conde de Valenciana Foundation
state: Mexico City
Study officials:
affiliation: Institute of Ophthalmology, Conde de Valenciana Foundation
name: Angel Nava-Castañeda, MD, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Ophthalmology, Conde de Valenciana Foundation
name: Yonathan O Garfias, MD, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: 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.