MANAGEMENT OF PRIMARY PTERYGIUM: EVALUATING THE COMPARATIVE EFFICACY AND SHORT-TERM OUTCOMES OF INTRALESIONAL MITOMYCIN C TO INTRALESIONAL INTERFERON ALPHA-2B AT THE EYE CLINIC OF LAGOS STATE UNIVERSITY TEACHING HOSPITAL, IKEJA - Trial PACTR202302902720138
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Study Focus
drug
Sponsor & Location
Dr. Maryam Fashola
Dr. Fashola Maryam
Timeline & Enrollment
Phase 4
Jan 01, 1900
Jan 01, 1900
Summary
Pterygium is a fibrovascular proliferation of degenerative conjunctiva with growth across the limbus, that may eventually encroach on the visual axis causing severe visual impairment or blindness. Surgery is the traditional modality of treatment of pterygium, usually offered when there is significant astigmatism, recurrent inflammation, cosmetic concerns or when the visual axis is threatened/obscured. Not many patients are open to surgery, and many patients default only to return with severe visual impairment or blindness from visual axis obscuration. Studies have found intralesional injections of agents such as mitomycin C (MMC), and anti-vascular endothelial growth factor (anti-VEGF) used alone or in combination with 5-fluorouracil (5-FU) for primary pterygium leads to regression, obviating the need to operate over 80% of eyes studied and significantly reducing the recurrence rates for those eyes that still required surgery. Mitomycin C in high doses is potentially toxic to the eyes. Interferon alpha-2b was found to be safer and equally efficacious in studies comparing it to mitomycin C in the management of ocular surface squamous neoplasia (OSSN). Topical interferon alpha-2b has also been used to reduce recurrence rates in up to 90% of eyes following surgical excision of pterygium. This study is a randomized control trial (RCT) to compare the efficacy and safety profile of low-dose mitomycin C to interferon alpha-2b given intralesionally in primary pterygium.
ICD-10 Classifications
Data Source
Pan Africa Clinical Trials Registry
PACTR202302902720138
Non-Device Trial

