2024-518482-99-01招募中4 期
Personalized treatment aided by automated analysis of fluid in active neovascular age-related macular degeneration (nAMD) in a prospective, multicenter, randomized study
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- - Number of anti-VEGF injections
研究概览
简要总结
The purpose of this study is to implement quantitative assessment tools for the treatment of active neovascular AMD patients in a real-world setting in order to provide advantages for both patients (treatment burden) and healthcare system (scheduling visits/treatments).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 50 years
- •Active neovascular AMD (classic, occult choroidal neovascularization (CNV), RAP lesion or PCV lesion) assessed by OCT, OCTA, FA
- •Patients who have a BCVA score better or equal 0.1 (20/200) in the study eye using ETDRS
- •No significant fibrosis or geographic atrophy (GA) involving the fovea
- •Willingness and ability to comply with study visits and study procedures
- •Signed informed consent form
排除标准
- •Hypersensitivity to Fluoresceine, Ranibizumab, Aflibercept, Brolucizumab or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)
- •Active or suspected ocular or periocular infection in the study eye
- •Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
- •Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment
- •Evidence of current infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
- •Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could cause an unwanted effect on treatment efficacy, compliance or require intraocular surgery (except for cataract surgery) during the study period
- •Presence of corneal decompensation, haze or scaring with an impact on BCVA
- •Any surgical treatment of the eye within 3 months prior to baseline in the study eye
- •History of pseudophakic cystoid macular edema (Irvine Gass Syndrome)
- •History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Visit 0, or a history of post-operative complications within the last 12 months preceding Visit 0 in the study eye (uveitis, cyclitis etc.)
- •History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio >0,9
- •Aphakia in the study eye
- •Presence of a retinal pigment epithelial tear involving the macula in the study eye
- •Any concurrent intraocular condition in the study eye (e.g. advanced cataract or diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the twelve-month study period to prevent or treat visual loss that might result from that condition
- •Active intraocular inflammation (grade trace or above) in the study eye
结局指标
主要结局
- Number of anti-VEGF injections
- Number of anti-VEGF injections
次要结局
- - Best-corrected visual acuity (BCVA) assessed by ETDRS Score
- - Anatomic changes in the macula assessed with OCT (central retinal thickness, fluid volumes in nl, additional morphologic changes)
- - Formation of geographic-like macular atrophy assessed by fundus photography with special filters
- - Formation of retinal tears assessed by OCT
- - Chorioretinal perfusion changes (OCTA)
- - Perfusion of the neovascular lesion (OCTA, FA)
- - Changes in macular sensitivity (MP)
- - Assessment of fibrosis formation and deterioration of the retinal pigment epithelium (PS-OCT)
- - Quality-of-life assessed by questionnaire
研究者
Department of Ophthalmology and Optometry
Scientific
Medical University Of Vienna
研究点 (2)
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