Health Condition 1: H308- Other chorioretinal inflammations
Conditions
Interventions
Intervention1: Adalimumab 40 mg subcutaneous injection every 2 weeks outcomes in adult non-infective uveitis management 1-year follow-up study: Adalimumab 40 mg subcutaneous injection every 2 weeks ef
outcomes include change in BCVA (logMAR), anterior chamber inflammation (SUN criteria), vitreous haze (NEI grading), macular edema (OCT), treatment discontinuation rate, adverse events (injection site
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Diagnosed with NIU requiring systemic treatment 3. 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. 4. 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). 5. Unable to maintain remission on 5mg or less prednisolone with or without other immunomodulators 6. Willingness to receive adalimumab therapy and participate in the study
Exclusion criteria
Exclusion criteria: 1. Possible to maintain remission on prednisolone 5 mg or less 2. Possible to maintain remission on immunomodulators with or without prednisolone in a dose of 5mg or less 3. Active or uncontrolled systemic infection 4. Active tuberculosis 5. Uncontrolled or significant medical conditions (e.g., severe cardiovascular disease, uncontrolled diabetes, active malignancy) 6. Pregnancy or breastfeeding 7. History of hypersensitivity to adalimumab or its components 8. Multiple sclerosis or other demyelinating diseases 9. Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy & Safety of Adalimumab in NIU. 2. Sub-group analysis of various parameters. 3. Long-term outcomes of Adalimumab treatmentTimepoint: 1.Participant recruitment: 6 months 2.Intervention and follow-up: 3 years 3.Data analysis and reporting: 6 months 3. Long-term outcomes of Adalimumab treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Visual Acuity Improvement 2.Reduction in Retinal Thickness 3.Incidence of Relapses or Flare-Ups 4.Quality of Life Improvements 5.Steroid-Sparing Effect 6.Adverse Events & Safety Profile 7.Inflammatory Marker Changes:Timepoint: Visual Acuity at baseline & follow-ups at 1, 3, 6 months, then every 6 months. Retinal Thickness at baseline & follow-ups at 3, 6, 12, 24, 36 months. Relapses recorded as they occur. Quality of Life at baseline & follow-ups at 6, 12, 24, 36 months. Steroid Sparing at baseline & all visits. Adverse Events continuously monitored. Inflammatory Markers at baseline & follow-ups at 6, 12, 24, 36 months. | — |
Countries
India
Contacts
Public ContactSANJAY KUMAR MISHRA
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029
Outcome results
None listed