JPRN-jRCT2031210120已完成3 期
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
Kobayashi Takeshi0 个研究点目标入组 485 人开始时间: 2021年5月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 485
研究概览
简要总结
The study met its primary objective, and similar efficacy between SOK583 and Eylea EU was shown. No clinically relevant differences in PK, safety, and immunogenicity were observed between the SOK583 and Eylea EU groups. Overall, the observed safety profile of SOK583 was in line with the established safety profile of Eylea.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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 pathologic myopia (spherical equivalent of 8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye
- •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. Retinal pigment epithelium (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
- •1)Intraocular (including cataract surgery) or refractive surgery within the 90 day periodprior to Baseline. The yttrium aluminum garnet (YAG) posterior capsulotomy is allowed no later than 4 weeks prior to Baseline
- •2)Previous penetrating keratoplasty or vitrectomy
- •3)Previous panretinal photocoagulation
- •4)Previous photodynamic therapy
- •5)Previous submacular surgery or other surgical intervention for AMD
- •6)Retinal detachment or treatment or surgery for retinal detachment
- •7)Any history of macular hole of stage 2 and above
- •8)Prior trabeculectomy or other filtration surgery
- •9)Ocular trauma within 6 months 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 Investigator
- •11. Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator 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 month 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 or surgical intervention during the course of the study
- •17. Presence of amblyopia, amaurosis or ocular disorders with BCVA <38
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