| CTRI Number |
CTRI/2024/12/078791 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effectiveness of lamivudine, an antiviral drug, in the treatment of eye nerve damage caused by injuries |
|
Scientific Title of Study
|
A Pilot Study to Assess the Efficacy of Oral Lamivudine in the treatment of Traumatic Optic Neuropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthik Kumar M |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital, Coimbatore |
| Address |
B5, Department of Neuro Ophthalmology,
Aravind Eye Hospital,
Avinashi Road, Sitra, Coimbatore
Coimbatore TAMIL NADU 641014 India |
| Phone |
9790980776 |
| Fax |
|
| Email |
karthikkumardr@aravind.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Karthik Kumar M |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital, Coimbatore |
| Address |
B5, Department of Neuro Ophthalmology,
Aravind Eye Hospital,
Avinashi Road, Sitra, Coimbatore
TAMIL NADU 641014 India |
| Phone |
9790980776 |
| Fax |
|
| Email |
karthikkumardr@aravind.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Karthik Kumar M |
| Designation |
Medical Consultant |
| Affiliation |
Aravind Eye Hospital, Coimbatore |
| Address |
B5, Department of Neuro Ophthalmology,
Aravind Eye Hospital,
Avinashi Road, Sitra, Coimbatore
TAMIL NADU 641014 India |
| Phone |
9790980776 |
| Fax |
|
| Email |
karthikkumardr@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital,
1, Anna Nagar, Madurai, Tamil Nadu, India, PIN code: 625020 |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital |
| Address |
1, Anna Nagar, Madurai, Tamil Nadu, PIN code: 625020 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karthik Kumar M |
Aravind Eye Hospital, Coimbatore |
B5, Neuro Ophthalmology services,
Aravind Eye Hospital,
Avinashi road, SITRA, Coimbatore Coimbatore TAMIL NADU |
9790980776
karthikkumardr@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee - PSG Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S040||Injury of optic nerve and pathways, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 with oral lamivudine 150mg twice daily for 2 months |
| Comparator Agent |
placebo |
This group will receive intravenous methyl prednisoloe 1 gram for 3 days followed by tapering doses of oral prednisolone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Best corrected visual acuity (BCVA) from baseline to 8 weeks. Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing chart |
baseline and week 1,2,4 and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 Tomography |
baseline and week 1,2,4 and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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
|