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CTRI Number  CTRI/2025/02/080590 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Adalimumab in Non-Infective Uveitis in Adults 
Scientific Title of Study   Prospective Analysis of Patients on Adalimumab for Non-Infective Uveitis in Adults: A 3-Year Follow-Up Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohan Chawla 
Designation  Additional Professor 
Affiliation  Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 
Address  Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  9891052939  
Fax    
Email  dr.rohanrpc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rohan Chawla 
Designation  Additional Professor 
Affiliation  Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 
Address  Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  9891052939  
Fax    
Email  dr.rohanrpc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rohan Chawla 
Designation  Additional Professor 
Affiliation  Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 
Address  Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029

South
DELHI
110029
India 
Phone  9891052939  
Fax    
Email  dr.rohanrpc@gmail.com  
 
Source of Monetary or Material Support  
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 
 
Primary Sponsor  
Name  AIIMS, New Delhi 
Address  Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 
Type of Sponsor  Government medical college 
 
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 Rohan Chawla  AIIMS, New Delhi  Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029
South
DELHI 
9891052939

dr.rohanrpc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institue Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H308||Other chorioretinal inflammations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosed with NIU requiring systemic treatment
Sight threatening uveitis cases which are started on Adalimumab therapy such as cases of chronic intermediate uveitis, choroiditis, vasculitis, or VKH will be predominantly included.
Both chronic and recurrent cases of above subtypes of uveitis on Adalimumab will be included. Definitions of chronic and recurrent is as per standardized uveitis nomenclature (International).
Unable to maintain remission on 5mg or less prednisolone with or without other immunomodulators
Willingness to receive adalimumab therapy and participate in the study 
 
ExclusionCriteria 
Details  Possible to maintain remission on prednisolone 5 mg or less
Possible to maintain remission on immunomodulators with or without prednisolone in a dose of 5mg or less
Active or uncontrolled systemic infection
Active tuberculosis
Uncontrolled or significant medical conditions (e.g., severe cardiovascular disease, uncontrolled diabetes, active malignancy)
Pregnancy or breastfeeding
History of hypersensitivity to adalimumab or its components
Multiple sclerosis or other demyelinating diseases
Inability or unwillingness to provide informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Improved treatment recommendations for patients with inadequate response to conventional therapies.
2. Development of personalized treatment strategies based on individual characteristics and response to adalimumab.
3. Enhanced understanding of the long-term safety profile of adalimumab. 
Baseline: Ophthalmic evaluation (e.g., visual acuity, IOP, anterior chamber cells, vitreous haze, OCT), lab tests, and disease history assessment.
Follow-Up:

1 Month: Initial response and side effects.
3 Months: Short-term efficacy and therapy adjustments.
6 Months: Monitor response and adverse events.
12 Months: Evaluate effectiveness and tolerability.
Years 2-3: Assess long-term outcomes and adherence.
Additional Visits: For flare-ups or complications. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   26/02/2025 
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="3"
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  

Background:

Non-infective uveitis is a major cause of vision loss in adults, characterized by inflammation in the eye’s uveal tract, which includes the iris, ciliary body, and choroid. If untreated, it can lead to severe complications like cataracts, glaucoma, macular edema, and permanent vision loss. Traditional treatments, including corticosteroids and immunosuppressive agents, are effective but often come with significant side effects and are not always well-tolerated by patients.

Adalimumab, a biologic agent that targets tumor necrosis factor (TNF)-alpha, has shown promise in the treatment of inflammatory conditions, including non-infective uveitis. While previous studies have demonstrated the efficacy of adalimumab in managing non-infective uveitis, there is limited data on its long-term effects and sustained benefits, especially in the Indian population.

Purpose of the Trial:

The primary objective of this study is to evaluate the effectiveness of adalimumab in the management of non-infective uveitis in adults, with a focus on its ability to control ocular inflammation and maintain remission over a period of 1 year. The trial aims to assess how well adalimumab controls uveitis inflammation, its impact on visual acuity, and its safety profile when used as a long-term treatment option.

This study will contribute to better understanding the role of adalimumab in managing chronic uveitis and could potentially offer a more effective and well-tolerated alternative to existing treatments. Additionally, the results may help establish guidelines for its use in clinical practice, particularly in cases of uveitis that are resistant to conventional therapies.

 
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