NCT05266495终止不适用
Effectiveness of Brolucizumab in Pretreated Patients With nAMD in the Real-world Setting in Gulf Countries United Arab of Emirates, Kuwait , Bahrain , Oman and Qatar
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Percentage of patients with absence of SRF and IRF
研究概览
简要总结
The study is a prospective and retrospective, observational, single-arm, non-randomized cohort study of ocular treatment with intravitreal injections of brolucizumab in nAMD patients. This study will be conducted prospectively and retrospectively (for patients who had their first brolucizumab injection before study start) using data collected in a standardized manner.
详细描述
Retrospective data will be collected for all patients starting treatment with brolucizumab for up to 12 months before baseline.
Patients who received brolucizumab before the study start will be recruited into the study and presented an informed consent form (ICF) at their first visit. Their index date will be the date of their first brolucizumab injection, which must have occurred during the recruitment period or in 6 months prior to the first visit in the recruitment period. Patient history and characteristics will be recorded in the 12 months prior to the index date.
Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in the patient study eye.
Index period: The patients fulfilling the inclusion criteria will be identified during the period 01-Nov-2021 and onwards.
Study period: The period is between May-2020 and Nov-2023 to allow 6-month pre-index period and at least a 12-month follow-up period for each recruited patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of nAMD
- •Patients with ≥18 years of age at index
- •Receipt of at least one injection of brolucizumab (not necessarily the first one) during the index period
- •Signed informed consent
排除标准
- •Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
- •Receipt of any anti-VEGF treatment other than brolucizumab in the study eye during the index period
- •Receipt of brolucizumab in the study eye more than 6 months before the index period, i.e., brolucizumab treatment started more than 6 months before the start of the study
- •Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date
- •Patients who have any contraindication and are not eligible for treatment with brolucizumab as according to the label
- •Patients who were treated with more than 2 types of anti-VEGF before index date (4th line brolucizumab patients or more)
- •Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 12-month study participation
- •Patients participating in parallel in an interventional clinical trial Note: if a patient experiences an adverse event (AE), they may still be recruited in another study following this AE if they fulfill their inclusion criteria. Their data will still be collected as planned by the current protocol
- •Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
结局指标
主要结局
Percentage of patients with absence of SRF and IRF
时间窗: Month 12
percentage of treated patients with absence of SRF and IRF. Patients who have discontinued brolucizumab before Month 12 will be counted as not having achieved the endpoint of fluid resolution (absence of SRF and IRF), unless they reached it at the last visit while still on brolucizumab treatment before the discontinuation.
次要结局
- Switch Patients: Number of injections in the last year before switching to brolucizumab(Baseline)
- Percentage of patients with the study eye that has VA equal or less than the VA in fellow eye(Baseline)
- Switch Patients: Last interval of anti-VEGF treatment before switching(Baseline)
- Percentage of patients with absence of SRF, IRF and sub-RPE(Month 3, Month 6, Month 9 and Month 12)
- Association between CST variability at Months 1-12 and VA change from baseline(Month 3, Month 6, Month 9 and Month 12)
- Association between CST variability at Months 1-12 and number of injections(Month 12)
- Percentage of patients with clinician-graded subretinal fibrosis and/or macular atrophy(Month 12)
- Percentage of patients with baseline visit(Baseline)
- Percentage of patients with baseline VA in the following categories (≤35, 36-69, ≥ 70 ETDRS letters)(Baseline)
- Percentage of patients with stable IRF(Month 3, Month 6, Month 9 and Month 12)
- Percentage of patients with VA between 34 and 72 ETDRS letters(Baseline)
- Time to absence of IRF during the 12-month treatment with brolucizumab(12 months)
- Percentage of patients with absence of sub-RPE(Month 3, Month 6, Month 9 and Month 12)
- Time to absence of IRF and SRF and sub-RPE during the 12-month treatment with brolucizumab(12 months)
- Estimate CST change from baseline(Month 3, Month 6, Month 9 and Month 12)
- Percentage of patients ≥ 80 years old(Baseline)
- Duration of diagnosis(Baseline)
- Percentage of patients with baseline VA < 73 ETDRS letters and active (SRF only)(Baseline)
- Percentage of patients with different ethnic groups(Baseline)
- Percentage of patients with stable SRF(Month 3, Month 6, Month 9 and Month 12)
- Time to absence of SRF during the 12-month treatment with brolucizumab(12 months)
- Baseline CST(Baseline, Month 3, Month 6, Month 9 and Month 12)
- Percentage of patients with absence of IRF(Month 3, Month 6, Month 9 and Month 12)
- Percentage of patients with bilateral disease(Baseline)
- Percentage of patients with lesion type(Baseline)
- Baseline VA(Baseline)
- Switch Patients: Previous anti-VEGF treatments of nAMD pre-treated patients(Baseline)
- Percentage of patients with reduced CST vs baseline(Baseline, Month 3, Month 6, Month 9 and Month 12)
- Switch Patients: Duration of previous anti-VEGF treatments(Baseline)
- Percentage of patients with absence of SRF(Month 3, Month 6, Month 9 and Month 12)
- Percentage of patients with stable sub-RPE(Month 3, Month 6, Month 9 and Month 12)
- Percentage of patients with presence of SRF, IRF and sub-RPE(Baseline)
- Time to absence of sub-RPE during the 12-month treatment with brolucizumab(12 months)
- VA change from baseline(Baseline, Month 3, Month 6, Month 9 and Month 12)
- Percentage of patients with VA change from baseline(Baseline, Month 3, Month 6, Month 9 and Month 12)
- Distribution of injection intervals(During Months 1-6 and 1-12)
- Percentage of patients with at least one duration of interval between injections(12 months)
- Number of participants by last recorded injection interval(Month 6 and Month 12)
- Percentage of patients with geographic atrophy(12 Months)
- Percentage of switchers with full loading phase(12 months)
- Percentage of patients with ≥ 70 ETDRS letters(Month 3, Month 6, Month 9 and Month 12)
- Number of brolucizumab visits(Over Months 1-3, 3-6, 6-12 and 1-12)
- Percentage of patients with at least two consecutive duration of intervals between injections(12 months)
- Percentage of switch patients from other anti-VEGF that prolonged injection intervals with brolucizumab(Month 6, Month 9 and Month 12)
- Number of visits with/without OCT(Over Months 1-6 and 1-12)
- Percentage of patients with ≥ 3 brolucizumab injections(Month 3)
- Time between two consecutive brolucizumab injections(Over Months 1-3)
- Association between number of OCT and VA change from baseline(Month 6, Month 9 and Month 12)
- Association between number of OCT and number of injections(12 months)
- Duration of brolucizumab treatment before switching(Up to month 12)
- VA at the end of the loading phase(Month 3)
- Association between number of OCT and CNV activity(Month 6, Month 9 and Month 12)
- proportion of participants by baseline CNV activity(Baseline)
- Proportion of participants with and without Loading phase(12 months)
- CNV activity at the end of the loading phase(Month 3)
- Number of injections during the maintenance phase(Over months 3-12)
- Percentage of patients with subretinal fibrosis(12 Months)
- Percentage of patients who switch to another anti-VEGF(6 Months, 9 Months and 12 Months)
- Reason for switching to another anti-VEGF(12 months)
- Last recorded injection interval before switching(Month 6 and Month 12)
- Days of persistence(Up to 12 Months)
- Assessment of criteria for no retreatment(12 months)
- VA at time of switch(Up to 12 months)
- Percentage of patients with activity at time of switch(Up to 12 months)
- Percentage of patients by injection rate at pre-switch period(Up to 12 months)
- Percentage of patients who discontinue therapy(Up to 12 months)
- Percentage of patients with AEs(12 Months)
- AE rate(Month 3, Month 6, Month 9 and Month 12)
研究者
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