The TITAN Study: Topical Infliximab for the Treatment of Advanced Corneal Melt and Ocular Surface Inflammation.

PURPOSE: Sterile corneal melt is a rare but serious condition that may occur secondary to chemical burns, inflammatory disorders, or autoimmune diseases. It is thought to be mediated by cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-1. Infliximab, a chimeric monoclonal antibody targeting TNF-α, has been used systemically in ocular inflammatory conditions. This study aims to evaluate the safety and preliminary efficacy of topical infliximab in treating sterile corneal melt in humans.

DESIGN

Prospective, single-center, unmasked, single-arm phase I/II clinical trial.

PARTICIPANTS

Patients presenting with sterile, culture-negative, corneal melt of any etiology at the Centre Hospitalier de l'Université de Montréal.

METHODS

Patients diagnosed with sterile corneal melt received topical infliximab 10 mg/mL eye drops 4 times daily for 4 weeks, in addition to standard care, and were followed for 12 weeks. Clinical evaluation, anterior segment OCT, and Ocular Surface Disease Index questionnaires were used to assess outcomes.

MAIN OUTCOME MEASURE: The primary outcome was the occurrence of adverse events; secondary outcomes included stabilization of corneal thinning and reepithelialization.

RESULTS

Six patients with etiologies received infliximab. The treatment was well tolerated, with no serious adverse events. One patient developed uveitis after discontinuation, that resolved with topical steroids. Corneal thinning stabilized in all patients, and 66% achieved complete re-epithelialization by 12 weeks. No surgical interventions were required.

CONCLUSIONS

Topical infliximab appears to be a safe and promising treatment for sterile corneal melt.

FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.