Interval of Disease Inactivity After Complete Polypoidal Regression on ICGA in Eyes With Polypoidal Choroidal Vasculopathy Following Intravitreous Aflibercept Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Interval of disease activity on color fundus photography or optical coherence tomography
研究概览
简要总结
Polypoidal choroidal vasculopathy (PCV), a subtype of neovascular age-related macular degeneration (NV AMD), is an important cause of central visual loss, especially among Asian and African descendants. PCV is characterized by the presence of hyperfluorescent polypoidal lesions, with or without branching vascular network, identified on indocyanine green angiography (ICGA), currently the gold standard for PCV diagnosis.
In addition to visual improvement from baseline, polypoidal regression or complete disappearance of polypoidal lesions on ICGA has been considered an important treatment outcome in large PCV trials including the PLANET1 and EVEREST II2 studies. Rate of polypoidal regression following intravitreous aflibercept monotherapy was 33% in the PLANET study1 year 2 and ranged between 55% to 78% in other Asian cohorts.3-4
Recently, our previous investigation5 on the timing of polypoidal regression following a fixed-dosing aflibercept monotherapy (3 initial monthly injections, then q 8 weeks until 1 year) in 40 Thai PCV eyes suggested that, among 22 eyes (55%) with polypoidal regression at 1 year, a majority of them showed complete polypoidal regression before 6 months (median duration of complete regression: 3 months (IQR, 2 months to 6 months).
However, due to the fixed-dosing regimen used in previous study, there are limited data on how often polypoidal lesions remain regressed on ICGA when the treatment is deferred in eyes with polypoidal regression, nor what changes might be seen subsequently on OCT when treatment is deferred in this situation. Therefore, this study aims to determine the changes seen on OCT subsequent to complete regression of polypoidal lesions on ICGA in PCV eyes following intravitreous aflibercept treatment.
Results from this study may provide some insights on longer-term PCV management
详细描述
Primary objective:
To determine how long there is CNV inactivity on OCT (absence of intraretinal thickening, intraretinal cystoid abnormalities, subretinal fluid, or enlarging pigment epithelial detachments) in eyes with complete polypoidal regression on ICGA after receiving intravitreous aflibercept injections over 2 years for PCV
Secondary objectives:
- To determine the rate of polypoidal regression compared with baseline at 3, 6, 12, and 24 months following intravitreous aflibercept "treat and extend" regimen
- To determine the visual acuity change from baseline to 1 and 2 years following intravitreous aflibercept "modified treat and extend" regimen and its correlation with OCT or ICGA activity.
- To determine the correlation of changes at week 12 with changes at 12 months and 24 months
- To determine the incidence of newly developed or recurrent polypoidal lesions in eyes with complete polypoidal regression after aflibercept treatment "treat and extend" regimen over 2 years
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of ≥18 years
- •Diagnosis of treatment-naïve PCV in either eye
- •PCV is defined according to the following criteria Presence of focal subretinal ICGA hyperfluorescence within the first 6 minutes, plus one of the followings; 1) subretinal orange nodule corresponds to hyperfluorescent nodule on ICGA, 2) massive submacular hemorrhage of 4 disc area or larger, 3) nodular appearance on stereoscopic viewing, 4) pulsatile polypoidal lesion, 5) abnormal vascular channel supplying the polypoidal lesion, 6) hypofluorescent halo around the nodule6
- •If any participant presents with bilateral PCV in which both eyes are eligible for the study, the eye with worse vision will be chosen as the study eye
排除标准
- •Presence of co-existing vision threatening conditions in the study eye, e.g., diabetic retinopathy, or retinal vascular occlusion
- •Presence of ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or any of the excipients in aflibercept
- •Inability to obtain good quality imaging due to ocular media abnormalities
- •Contraindicate for FFA or ICGA due to the following conditions:
- •Allergic to fluorescein or indocyanine green dye
- •Allergic to iodine or seafood
- •Impaired kidney or liver functions
- •Not able to follow up according to the study protocol
研究组 & 干预措施
complete polypoidal regression arm
follow up monthly with color fundus photography and OCT at each visit
干预措施: Defer treatment (Other)
incomplete polypoidal regression arm
continue treatment with aflibercept injection (treat and extend regimen)
干预措施: Aflibercept Injection (2 mg/0.05 ml) (Drug)
结局指标
主要结局
Interval of disease activity on color fundus photography or optical coherence tomography
时间窗: 1 to 24 months
* Disease inactivity on color fundus photography is defined as an absence of new retinal or subretinal or sub-RPE hemorrhage on color fundus photography compared with baseline * Disease inactivity on OCT is defined as an absence of intraretinal thickening or CME or subretinal fluid or PED or enlarging PED on OCT
次要结局
未报告次要终点
研究者
Voraporn Chaikitmongkol
Assistant Professor
Chiang Mai University