Economic Impact and Patient Outcomes of Anti-VEGF Therapy in Diabetic Macular Edema: A Comparative Cost Analysis in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Improvement in best-corrected visual acuity (BCVA) measured in ETDRS letters, used to determine cost-effectiveness of anti-VEGF therapy versus comparators.
研究概览
简要总结
Background: Diabetic Macular Edema (DME) is a major cause of vision loss among individuals with diabetes. Anti-VEGF therapy has revolutionized DME management by significantly improving visual outcomes. However, the high cost of anti-VEGF agents raises concerns about their affordability and cost-effectiveness, particularly in resource-constrained public healthcare systems such as in India.
Purpose: This study aims to evaluate the cost-effectiveness of anti-VEGF therapy compared to alternative treatments (e.g., corticosteroids and laser therapy) in patients with DME, treated at a government-funded tertiary eye care center (Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi).
Objectives:
- Primary Objective: To determine the incremental cost-effectiveness ratio (ICER) of anti-VEGF therapy in comparison to laser and corticosteroid treatments.
- Secondary Objectives: To assess clinical outcomes (change in BCVA and CMT), estimate direct and indirect costs, and evaluate the economic burden of DME from the patient and health system perspective.
Methods: A retrospective cohort study will be conducted, reviewing medical records of DME patients treated between January 2018 and March 2025. Data on visual acuity, OCT findings, number of injections, and treatment costs will be collected. ICER will be calculated using changes in ETDRS letters and cost data. Quality of life and indirect costs will be assessed via a validated questionnaire.
Sample Size: Based on an expected moderate effect size in cost-effectiveness between treatment groups and accounting for subgroup analysis, approximately 160 patients will be included.
Data Analysis: Cost-effectiveness will be expressed as ICER per ETDRS letter gained. Descriptive statistics, comparative tests, and sensitivity analyses will be conducted to test robustness of results.
Expected Outcome: The study is expected to provide data on whether anti-VEGF therapy offers good value for money in the management of DME, thereby informing clinical and policy decisions for optimizing eye care resources in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with center-involving diabetic macular edema (CI-DME) confirmed by optical coherence tomography (OCT).
- •2.Age more than 18 years at the time of first treatment.
- •3.Received anti-VEGF therapy (Ranibizumab, Aflibercept, or Bevacizumab) between January 2018 and March 2025 at Dr. R.
- •Centre for Ophthalmic Sciences, AIIMS, New Delhi.
- •4.Minimum follow-up duration of 6 months post initial anti-VEGF injection.
- •5.Availability of complete clinical records including: a.Best-corrected visual acuity (BCVA) b.Central retinal thickness (CRT) c.Cost data (direct and indirect) 6.Patients who have provided general consent for retrospective use of data or where waiver of consent is approved by the ethics committee.
排除标准
- •1.Eyes with prior vitreoretinal surgery or any intraocular surgery (except uncomplicated cataract surgery) within 6 months before anti-VEGF initiation.
- •2.Co-existing ocular diseases affecting vision (e.g., age-related macular degeneration, retinal vein occlusion, advanced glaucoma).
- •3.Patients who received combination therapy (e.g., anti-VEGF + steroid or laser) during the study period (unless separate groups are analyzed).
- •4.Inadequate imaging or clinical data preventing assessment of visual or anatomical outcomes.
- •5.Non-adherence to treatment or follow-up, resulting in fewer than 3 documented visits post initiation.
- •6.History of systemic conditions severely affecting functional status or vision-related quality of life assessment (e.g., stroke, severe neurological disorders).
结局指标
主要结局
Improvement in best-corrected visual acuity (BCVA) measured in ETDRS letters, used to determine cost-effectiveness of anti-VEGF therapy versus comparators.
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, and 52 weeks (12 months).
次要结局
- Change in best-corrected visual acuity (BCVA) in ETDRS letters
研究者
Dr Sanjay Kumar Mishra
AIIMS, New Delhi