CTRI/2020/08/027015进行中（未招募）3 期
A Phase III Randomized, Double-Masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity between SCD411 and Eylea® in Subjects with Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 560
- 试验地点
- 10
- 主要终点
- • To prove the equivalence of SCD411 as compared to Eylea (aflibercept) in best corrected visual acuity (BCVA) after 8 weeks of treatment among subjects with wet AMD.
研究概览
简要总结
This is a Phase III, randomized, parallel-group, double-masked, multicenter study in adult subjects with neovascular (wet) AMD. Subjects will be randomly assigned in 1:1 ratio using Interactive Response Technology to receive either SCD411 or aflibercept injections. Subjects will receive their randomized first IVT injection on Day 1 and subsequent IVT injection on Weeks 4, 8, 16, 24, 32, 40, and 48. The End-of-Treatment (EOT) Visit will be scheduled for Week 48 for those who receive all the scheduled injections. Subjects who discontinue the study treatment are expected to come for the Early Termination (ET) Visit as soon as possible after discontinuing the study treatment but no later than 28 days after discontinuation. The End-of-Study (EOS) Visit will occur 28 days after the end of treatment. Subjects and study site staff involved in subject management and study assessments will be masked to study treatment assignment. The investigator involved in performing the IVT injections will be unmasked to study treatment.
Approximately 560 subjects with wet AMD will be enrolled in this study across approximately 155 sites in 14 countries.
Eyleahas been approved for the treatment of wet AMD when administered as IVT injection of 2 mg (0.05 ml) every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 ml) injection once every 8 weeks (2 months). This dosage has been found to be efficacious in subjects with wet AMD and has an acceptable safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements
- •Age ≥50 years
- •Active choroidal neovascularization lesions secondary to AMD evidenced by fluorescein angiography (FA) in the study eye at screening and confirmed by the central reading center
- •The BCVA letter score of 73 to 35 using original series Early Treatment Diabetic Retinopathy Study (ETDRS) charts or 2702 series number charts in the study eye at screening and at Week 0 (Day 1) prior to randomization.
- •In addition, fellow eye should not be less than 35 letter score using the ETDRS chart or 2702 series number chart
- •Women of child-bearing potential with a negative serum pregnancy test at screening must agree to use protocol defined methods of contraception throughout the study until 3 months after the last injection of aflibercept/SCD411
- •Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm throughout the study until 3 months after the last injection of aflibercept/SCD411.
排除标准
- •Any prior ocular (in the study eye and fellow eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins
- •Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins
- •Fellow eye shows signs of AMD that, in investigator’s medical opinion, may need any treatment during study period
- •Any prior treatment with anti-vascular endothelial growth factor (VEGF) agents in the both eyes (ie, completely treatment naïve subjects only to be included)
- •Total lesion size >30.5 mm2, including blood, scars, atrophy, fibrosis, and neovascularization as assessed by FA in the study eye and confirmed by the central reading center
- •Central retina thickness of <300 µm in the study eye and confirmed by the central reading center
- •Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye and confirmed by the central reading center.
- •(If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible CNV)
- •Scar or fibrosis, making up >50% of the total lesion in the study eye and confirmed by the central reading center
- •Scar, fibrosis, or atrophy involving the center of the fovea in the study eye and confirmed by the central reading center
- •Presence of retinal pigment epithelial tears or rips involving the macula in the study eye and confirmed by the central reading center
- •Lens Opacity Classification System II (LOCS II) grade IV cataract in the study eye, or other significant cataract in the study eye that in the Investigator’s opinion interferes with visualization of retina or interferes with retinal imaging
- •Active extraocular inflammation in either eye or intraocular inflammation in study eye
- •Presence of other causes of CNV in the study eye as confirmed by central reading center
- •History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any other vascular disease affecting the retina, other than AMD, in either eye
- •Prior vitrectomy in the study eye
- •History of retinal detachment, treatment, or surgery for retinal detachment in the study eye
- •History of macular hole of Stage 2 and above in the study eye as confirmed by central reading center
- •History of uncomplicated intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1 Note: A subject with uncomplicated neodymium yttrium aluminum garnet (Nd:YAG) laser capsulotomy performed for secondary opacification of the posterior capsule in intraocular lens implanted eye within 3 months prior to Day 1 in the study eye will be considered as eligible.
- •History of glaucoma-filtering surgery within 3 months of Day 1 in the study eye.
- •Anti-glaucoma laser surgeries will not be considered exclusionary.
- •History of corneal transplant in the study eye.
- •History or evidence of any other clinically significant disorder, condition or disease (eg, co-existence of retinal vein occlusion, radiation retinopathy, diabetic retinopathy, glaucoma under treatment) in the study eye that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedure or complication
- •Uncontrolled hypertension defined as systolic blood pressure (BP) >180 mmHg or diastolic BP >100 mmHg under appropriate antihypertensive treatment
- •Hypersensitivity to aflibercept or medications used in this study (fluorescein, mydriatic eye drops, etc.)
- •Pregnancy or lactation at the Screening Visit and/or at baseline for women of child-bearing potential
- •History of thrombotic events (eg, stroke, transient ischemic attacks, pulmonary embolism, deep vein thrombosis, or myocardial infarction)
- •History or evidence of cardiac conditions including congestive cardiac failure leading to marked limitation on physical activity, or inability to perform any physical activity without discomfort, ventricular arrhythmia requiring ongoing treatment, and atrial fibrillation
- •History of laser therapy in the macular region in the study eye
- •Any prior or concomitant treatment with IVT corticosteroids injection, IVT corticosteroid implant, subtenon corticosteroids, or peribulbar corticosteroids in the study eye 6 months before the Screening Visit Note: For IVT corticosteroid implant, the exclusion period would be 36 months from the date of the procedure to the date of screening
- •Any prior or concomitant treatment involving the macula with photodynamic therapy with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser treatment (eg, focal laser photocoagulation) in the study eye
- •Any concomitant or prior treatment with ethambutol (2 weeks prior to randomization); deferoxamine and topiramate (4 weeks prior to randomization); tamoxifen, hydroxychloroquine, chloroquine, or vigabatrin (8 weeks prior to randomization), and amiodarone (12 weeks prior to randomization)
- •Any investigational product for the treatment of ocular conditions (in either eye) and systemic conditions 30 days or 5 half-lives (whichever is longer), prior to randomization, and throughout the study, except dietary supplements or vitamins.
结局指标
主要结局
• To prove the equivalence of SCD411 as compared to Eylea (aflibercept) in best corrected visual acuity (BCVA) after 8 weeks of treatment among subjects with wet AMD.
时间窗: • Change from baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts at Week 8.
次要结局
- - To compare the safety and tolerability of SCD411 and aflibercept(- To compare the efficacy of SCD411 and aflibercept after 8 weeks and 52 weeks of treatment demonstrated by BCVA, central retinal thickness (CRT), and CNV)
研究者
研究点 (10)
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