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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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