A 52-week multicenter, randomized, double-masked, 2-arm parallel study to compare efficacy, safety and immunogenicity of SOK583A1 to Eylea®, administered intravitreally, in patients with neovascular age-related macular degeneration - MYLIGHT

Hexal AG0 个研究点目标入组 460 人开始时间: 2021年1月27日最近更新: 2024年3月18日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Hexal AG
入组人数: 460

研究概览入排标准研究者记录与标识符相似试验

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

•Participants eligible for inclusion in this study must meet all of the following criteria:
•1.Signed informed consent must be obtained prior to participation in the study
•2.Participants must be 50 years of age or older at Screening
•3.Anti-VEGF treatment-naive patients for either eye and systemically
•4. Study eye diagnosed with active CNV lesions (type 1 and/or type 2) secondary to AMD and/or Retinal Angiomatous Proliferation lesions (type 3), affecting the central subfield. Active CNV lesion is defined by the presence of leakage as evidenced by fluorescein angiography, and intra- or subretinal fluid as evidenced by optical coherence tomography, both confirmed by the CRC at Screening
•5.Total area of CNV (including both classic and occult components) must comprise > 50% of the total lesion area in the study eye, confirmed by the CRC at Screening
•6.BCVA between 73 and 38 letters, both inclusive, in the study eye at Screening and Baseline using ETDRS testing charts
•7.Willing and able to comply with all study procedures, and be likely to complete the study
•8.Clear ocular media and adequate pupil dilatation in both eyes to permit good quality photographic imaging
•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 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 414

排除标准

•Participants meeting any of the following criteria are not eligible for inclusion in this study.
•Ocular conditions and treatments:
•1.Previous treatment with any anti-VEGF therapy in either eye or investigational drugs in study eye or fellow eye, at any time prior to Baseline
•2.Participant has received any approved treatment for nAMD (other than vitamin and dietary supplements) in the study eye and at any time prior the Baseline
•3.Presence of other causes of CNV, including diabetic retinopathy, pathologic myopia (spherical equivalent of –8 diopters or more negative), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye, assessed by imaging at screening
•by CRC and appropriately stated in multi-modal eligibility confirmation report
•4.Any active or suspected intraocular or periocular infection or active or suspected intraocular inflammation (e.g infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in either eye at Screening or Baseline
•5.Subfoveal fibrosis, atrophy, or scarring extending > 50% of total lesion area in the study eye as assessed by the Investigator at Screening and confirmed by the CRC prior to randomization
•6.Subretinal hemorrhage that is = 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involving the fovea is 1 or more disc areas (= 2.54 mm2 ) in size in the study eye, as assessed by FA and confirmed by the CRC
•7.RPE rip/tear in the study eye at Screening or Baseline
•8.Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline
•9.History or evidence of the following, in the study eye:
•Intraocular (including cataract surgery) or refractive surgery within the 90 day period prior to Baseline. The YAG posterior capsulotomy is allowed no later than 4 weeks prior to Baseline
•Previous penetrating keratoplasty or vitrectomy
•Previous panretinal photocoagulation or photodynamic therapy
•Previous submacular surgery or other surgical intervention for AMD
•Retinal detachment or treatment or surgery for retinal detachment
•Any history of macular hole of stage 2 and above
•Prior trabeculectomy or other filtration surgery
•Ocular trauma within 6-months period prior to Baseline
•10.History of hypersensitivity to any of the study treatments or its excipients, or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigators
•11.Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to Investigator’s judgment at Screening or Baseline
•12.Aphakia and/or absence of the posterior capsule in the study eye at Screening or Baseline, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
•13.Intra or periocular use of corticosteroids in the study eye within a 6 period prior to Baseline
•14.Use of topical ocular corticosteroids in the study eye for 30 or more consecutive days within the 90 days period prior to Baseline
•15.Previous therapeutic radiation near the region of the study eye
•16.Concomitant conditions or ocular disorders in the study eye, including media opacities, cataract and diabetic macular edema, at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results (efficacy and safety), compromise visual acuity or require medical o

研究者

发起方

Hexal AG

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