EUCTR2021-001058-73-CZ进行中（未招募）1 期
Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation - ProspectiveRandomised Study - Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. age of 50 years or more at the time the informed consent is signed
- •2. active RAP in the macula including fovea diagnosed on OCT and OCT angiography (OCTa)
- •3. BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen
- •equivalent) in the study eye
- •4. decrease in BCVA caused primarily by the RAP in the study eye
- •5. presence of intra- or subretinal fluid or PED in the central 1 mm of the
- •macula on the OCT
- •6. patient capable of signing the informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. other causes of choroidal neovascular membrane (CNV) than wAMD
- •2. previous or current conditions of the study eye:
- •a. subretinal haemorrhage comprising more than 25% of the lesion in the study eye
- •b. scar or fibrosis comprising more than 50% of the lesion in the study eye
- •c. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
- •d. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
- •e. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
- •f. idiopathic or autoimmune uveitis in the study eye
- •g. other pathologies in the macula of the study eye which can be expected to influence the BCVA (e.g. macular hole, retinal atrophy, epiretinal membrane, etc.)
- •h. history of glaucoma surgery in the study eye or probability that it will be necessary in the future
- •i. aphakia or pseudophakia with absence of the posterior lens capsule (with the exception of missing posterior capsule due to Nd:YAG laser capsulotomy) in the study eye
- •j. myopia in the study eye with spherical equivalent of more than 8 dioptries before any refractive or cataract surgery
- •k. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or FP or OCT examination
- •l. corneal transplantation or corneal dystrophy in the study eye
- •m. irregular astigmatism or BCVA-lowering amblyopia in the study eye
- •n. diabetic retinopathy, diabetic macular edema or any other retinal
- •vascular disease in the study eye
- •o. extraocular or periocular infection or inflammation (e.g. blepharitis,
- •keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of
- •screening or baseline visit
- •p. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
- •q. previous treatment with intravitreal or periocular antiVEGF or corticosteroids in the study eye
- •r. treatment with systemic intravenous antiVEGF or corticosteroids during 12 weeks (84 days) before the screening visit
- •3. allergy or hypersensitivity to any component contained in the study
- •4. pregnant or breastfeeding women
研究者
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