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A study to assess the effectiveness of lamivudine, an antiviral drug, in the treatment of eye nerve damage caused by injuries

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078791
Enrollment
30
Registered
2024-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S040- Injury of optic nerve and pathways

Interventions

Intervention1: Lamivudine: Oral tablet - 150mg twice daily for 2 months This group will receive intravenous methyl prednisoloe 1 gram for 3 days followed by tapering doses of oral prednisolone along

Sponsors

Aravind Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patient age of 18 years or older 2)Clinical diagnosis of traumatic optic neuropathy within 2 weeks of injury. 3)Best corrected visual acuity (BCVA) between 20/40 and light perception in the affected eye. 4)Ability to provide informed consent.

Exclusion criteria

Exclusion criteria: 1)Pregnant patients, currently lactating patients, or females of childbearing potential (unless using reliable contraception such as double barrier, surgical sterilization, oral contraceptives, intrauterine device (IUD), etc. 2)Prior history of optic neuropathy or other ocular diseases. 3)Known hypersensitivity to Lamivudine or any component of the formulation. 4)Positive ELISA for HIV. 5)Abnormal liver function tests

Design outcomes

Primary

MeasureTime frame
Mean change in Best corrected visual acuity (BCVA) from baseline to 8 weeks. Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing chartTimepoint: baseline and week 1,2,4 and 8 weeks

Secondary

MeasureTime frame
Changes in color vision, visual field, contrast sensitivity, Visual Evoked potential, peripapillary retinal nerve fibre layer thickness and macular Ganglion cell complex thickness by Optical Coherence TomographyTimepoint: baseline and week 1,2,4 and 8 weeks

Countries

India

Contacts

Public ContactDr Karthik Kumar M

Aravind Eye Hospital, Coimbatore

karthikkumardr@aravind.org9790980776

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026