| 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
|
|
|
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
|
|
|
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
|
|
|
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. |