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CTRI Number  CTRI/2025/09/095289 [Registered on: 23/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Study on the Effect and Safety of 3-Weekly Intravenous Methylprednisolone Treatment in People with Active, Moderate-to-Severe Thyroid Eye Disease, Measuring Changes in Eye Activity and Appearance 
Scientific Title of Study   Evaluation of the Efficacy and Safety of Intravenous Methylprednisolone Pulse Therapy in Patients with Active, Moderate to Severe Thyroid Eye Disease: A Prospective Observational Study 
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 MEGHA YOGESH JANGLE 
Designation  POST DO DNB resident  
Affiliation  Aravind Eye Hospital, Poonamallee 
Address  Aravind Eye Hospital, room number 103, Department of Orbit, Poonamallee high road, Numbal, Poonamallee, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9104402696  
Fax    
Email  meghajangle155@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayashree B 
Designation  HOD- Orbit and Oculoplasty Department  
Affiliation  Aravind Eye Hospital, Poonamallee 
Address  Aravind Eye Hospital, room number 103, Department of Orbit, Poonamallee high road, Numbal, Poonamallee, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9104402696  
Fax    
Email  jayashreedr@aravind.org  
 
Details of Contact Person
Public Query
 
Name  Dr MEGHA YOGESH JANGLE 
Designation  POST DO DNB resident  
Affiliation  Aravind Eye Hospital, Poonamallee 
Address  Aravind Eye Hospital, room number 103, Department of Orbit, Poonamallee high road, Numbal, Poonamallee, Chennai

Chennai
TAMIL NADU
600077
India 
Phone  9104402696  
Fax    
Email  meghajangle155@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Aravind eye hospital 
Address  Room number 103, Department of Orbit, Poonamallee high road, Numbal, Poonamallee, Chennai, 600077, Tamil Nadu, India  
Type of Sponsor  Private hospital/clinic 
 
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 MEGHA YOGESH JANGLE  Aravind Eye Hospital  Room number 103, Department of Orbit, Poonamallee high road, Numbal, Poonamallee, Chennai, Tamil Nadu
Chennai
TAMIL NADU 
9104402696

meghajangle155@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital, Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H051||Chronic inflammatory disorders oforbit,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosis of moderate-to-severe active TED with CAS more than 3, with normal renal and liver function test and written consent form taken
 
 
ExclusionCriteria 
Details  Sight threatening TED, Previous orbital radiotherapy or decompression surgery, History of steroid intolerance or contraindication, Uncontrolled systemic illnesses, Pregnancy or lactation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
High patient tolerance and compliance with the 3-weekly IV regimen due to fewer hospital visits and manageable side effects.
Reduction in Clinical Activity Score (CAS) and VISA score indicating decreased orbital inflammation and disease activity.

 
12 months  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   14/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Thyroid Eye Disease is an autoimmune inflammatory disorder that can cause proptosis, diplopia, and vision-threatening complications. High-dose corticosteroids are the mainstay of treatment, with weekly intravenous methylprednisolone pulses recommended by EUGOGO guidelines as first-line therapy. However, weekly protocols require frequent hospital visits and can increase healthcare burden and patient dropout rates. This study aims to evaluate the efficacy and safety of a 3-weekly IVMP pulse regimen which is, 1 g IVMP daily for 3 days as induction, followed by 500 mg IVMP every 3 weeks for 5 cycles in patients with active, moderate-to-severe TED. Outcomes will be assessed using Clinical Activity Score and VISA scoring at baseline and at each follow-up visit to monitor improvement in inflammation, proptosis, strabismus, and visual function. The study expects to demonstrate comparable efficacy to weekly regimens, improved patient compliance, and a favorable safety profile, potentially offering a more convenient and resource-efficient alternative for TED management.


 
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