Prospective Analysis of Patients on Adalimumab for Non-Infective Uveitis in Adults: A 3-Year Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Improved treatment recommendations for patients with inadequate response to conventional therapies.
研究概览
简要总结
**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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. Improved treatment recommendations for patients with inadequate response to conventional therapies.
时间窗: 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.
2. Development of personalized treatment strategies based on individual characteristics and response to adalimumab.
时间窗: 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.
3. Enhanced understanding of the long-term safety profile of adalimumab.
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr Rohan Chawla
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029