A Pilot Study to Assess the Efficacy of Oral Lamivudine in the treatment of Traumatic Optic Neuropathy

Introduction:

Traumatic Optic Neuropathy (TON) is a vision threatening disorder resulting from damage to the optic nerve by ocular or head trauma. More than 50% of patients with TON progress to complete permanent blindness, and a large proportion of the remainder experience partial vision loss. The current treatment guidelines on the treatment of TON are unclear, with unproven efficacy, thereby providing a very poor prognosis.

Review of Literature:

Lamivudine is a Nucleoside Reverse Transcriptase Inhibitor(NRTI) being used to control disease activity in people living with HIV/ AIDS (PLHA). The novelty behind this drug is that beyond its antiviral activity, recent studies have demonstrated that Lamivudine possesses significant anti-inflammatory and neuroprotective properties, thus making it a potential therapeutic agent for various neurodegenerative and inflammatory conditions.

Justification for the study:

Traumatic optic neuropathy, resulting from ocular or head trauma, commonly leads to loss of vision due to its pathophysiology of axonal damage, inflammation, and secondary ischemic injury. Management is challenging due to the complex nature of optic nerve injuries and the limited effectiveness of current treatments. Given the inflammatory component of TON, counterating it with Lamivudine’s anti-inflammatory properties makes it a promising candidate for treatment. By inhibiting NLRP3 inflammasome, Lamivudine could potentially reduce inflammation and prevent further damage to the optic nerve following trauma. This hypothesis is supported by preclinical evidence showing the efficacy of NRTIs in reducing inflammation and protecting retinal cells.

Major objective:

To assess the efficacy of oral lamivudine in improving visual outcomes in patients with traumatic optic neuropathy

Study design:

Randomised, single blind clinical trial

Patients will be randomly assigned to one of two groups:

Control group: three doses of intravenous methyl prednisolone 1g once daily for 3 days followed by tapering doses of oral prednisolone for 1 month.

Intervention group: The same regimen as control group plus oral Lamivudine 150mg twice daily for 2 months.

Risk and benefits:

Most common adverse events include nausea, dizziness, fatigue, malaise, headache, dreams, insomnia and skin rash. Laboratory abnormalities are uncommon with Lamivudine. Possible benefits include visual recovery , also possible approval of lamivudine as an oral drug for treatment of traumatic optic neuropathy