TOPICAL BEVACIZUMAB 0.05% EYE DROPS: A RANDOMIZED CONTROLLED TRIAL
BALAI KESEHATAN INDRA MASYARAKAT Disusun oleh :
FAKULTAS KEDOKTERAN UNIVERSITAS ISLAM SULTAN AGUNG Fawzia Haura Fathin, S.Ked SEMARANG 2017 Pembimbing : dr. Desti Hendrastuti, Sp. M INTRODUCTION Pterygium is a degenerative and proliferative fibrovascular disorder of the ocular surface, usually a triangular or wing shaped tissue, extending from the conjunctiva onto the cornea.
Various adjunctive measures are applied to prevent recurrence of pterygia after
excision, including medical and surgical methods.
Bevacizumab inhibits proliferation of endothelial cells and formation of new blood
vessels, the drug was suggested as a potential adjunctive treatment after pterygial excision To assessed the efficacy and tolerability of topical PURPOSE bevacizumab 0.05% when used as an adjunctive therapy after excision of primary pterygia. METHODS
Design • Randomized Controlled Trial
• Department of Ophtalmology, Place King Chulalongkorn Memorial Hospital Inclution Criteria :
• Patients diagnosed with primary pterygia and
scheduled for a pterygial excision with the use of the bare sclera technique were enrolled consecutively.
Exclution Criteria :
• Patients with corneal melt, corneal epitheliopathy,
and abnormal healing of a corneal epithelial wound, and those who were pregnant, lactating, or allergic to bevacizumab or steroids were excluded. The bevacizumab The control group group (10eyes,10patients) (12eyes,12patients) • Received normal saline • Received bevacizumab eye drops 4 times daily 0.05 % eye drops for 3 months.
All patients and an outcomes assessor were
blinded to the treatment assignments. RESULT & DISCUSSION The outcomes assessor was masked before data analysis. Three months after medications were started, most patients in the bevacizumab group had a grade 1 recurrence, whereas most patients in the placebo group had a grade 2 recurrence. One and 3 patients in the bevacizumab and the placebo groups, respectively, developed true recurrence (grade4). The recurrence rates between the groups did not differ significantly (P ¼ 0.29). Four (33.33%) and 9 (90.00%) patients in the bevacizumab and placebo groups, respectively, had conjunctival and cornea recurrences (grades2–4). The recurrence rates for grades 2 to 4 differed significantly between the groups (P ¼ 0.01) (Table III). Recurrence of pterygia is a major complication after pterygium surgery. Although the pathogenesis for recurrent pterygia was studied widely, the mechanism remains unknown. The typical degenerative connective tissue changes seen in primary pterygia are absent in the histologic findings in recurrent pterygia. Recurrent pterygia often have more exuberant fibrovascular growth. Many growth factors, including VEGF, fibroblast growth factor, platelet-derived growth factor, transforming growth factor-β, and tumor necrosis factor-α were found in pterygial tissues and are believed to play a key role in the formation of the fibrovascular tissue in recurrent pterygia. Bevacizumabisamonoclonalantibodythatblocks VEGF- A.Previously,2different modalitiesofbevacizu- mab wereinvestigatedforthetreatmentofprimary pterygia:subconjunctivalbevacizumabaloneorasan adjunctive therapyafterpterygialexcision.Tworandom- ized controlledtrials,12,13 1 caseseries,14 and 1case report,15 foundthatsubconjunctivalbevacizumabre- duced thesymptomsandsizesofpterygia,butthe effectwastemporaryand not clinicallyrelevant.12–15 Furthermore,Razeghinejadetal16 andShenasietal17 reportedthatsubconjunctivalbevacizumabusedasan adjunctive therapyafterprimarypterygialsurgerydidnot significantly preventrecurrenceofpterygia,eventhough thetreatmentwaswelltolerated.Thereasonforthismay be becauseoftheshort-termtemporaryeffectofthedrug LIMITATIONS The limitations of this study were the small number of patients and the short follow-up period. Moreover, until now no standard regimens for both the concen- trations and frequencies of the drugs have been used. The various concentrations and regimens of bevaci- zumab eye drops used to prevent pterygial recurrence should be studied to address these limitations. CONCLUSIONS Topical bevacizumab 0.05 %, as an adjunctive treatment after pterygial excision for 3 months, tended to lower the combined rate of conjunctival and corneal recurrences compared with placebo.
However, the rates of corneal recurrence at 3 months did not differ
significantly between topical bevacizumab 0.05 % and placebo. No significant local and systemic side effects developed in association with instillation of topical bevacizumab. THANKYOU