EUCTR2019-004132-37-PL进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 560
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. Capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
- •2. Age =50 years.
- •3. Active choroidal subfoveal, juxtafoveal, or extrafoveal neovascularization lesions secondary to AMD evidenced by fluorescein angiography (FA) in the study eye at screening and confirmed by the central reading center.
- •4. The BCVA letter score of 73 to 35 using original series 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
- •5. 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 (Section 4.1.3 and Section 4.1.4).
- •6. 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.
- •7. The area of CNV making up either 50% or more of the total lesion area and confirmed by the central reading center.
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 392
排除标准
- •1.Any prior ocular (in the study eye and fellow eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins
- •2.Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins
- •3.Fellow eye shows signs of AMD that, in investigator’s medical opinion, may need any treatment during study period
- •4.Any prior treatment with anti-VEGF agents in the both eyes
- •5.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
- •6.Central retina thickness of <300 µm in the study eye and confirmed by the central reading center
- •7.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.
- •8.Scar or fibrosis, making up >50% of the total lesion in the study eye and confirmed by the central reading center
- •9.Scar, fibrosis, or atrophy involving the center of the fovea in the study eye and confirmed by the central reading center
- •10.Presence of retinal pigment epithelial tears or rips involving the macula in the study eye and confirmed by the central reading center
- •11.Lens Opacity Classification System 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
- •12.Active intraocular/periocular infection and inflammation in either eye
- •13.History of any vitreous hemorrhage in the study eye within 4 wks prior to the Screening Visit
- •14.Presence of other causes of CNV in the study eye as confirmed by central reading center
- •15.History or clinical evidence of diabetic retinopathy, DME, or any other vascular disease affecting the retina, other than AMD, in either eye
- •16.Prior vitrectomy in the study eye
- •17.History of retinal detachment, treatment, or surgery for retinal detachment in the study eye
- •18.History of macular hole of Stage 2 and above in the study eye as confirmed by central reading center
- •19.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
- •20.Presence of aphakia in the study eye
- •21.History of glaucoma-filtering surgery within 3 months of Day 1 in the study eye. Antiglaucoma laser surgeries will not be considered exclusionary.
- •22.History of corneal transplant in the study eye
- •23.History or evidence of any other clinically significant disorder, condition or disease 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
- •24.Uncontrolled hypertension defined as systolic BP >160 mmHg or diastolic BP >100 mmHg under appropriate antihypertensive treatment
- •25.Hypersensitivity to aflibercept or medications used in this study
- •26.Pregnancy or lactation at the Screening Visit and/or at baseline for women of child-bearing potential
- •27.Any contraindication to IVT injection according to the investigator’s clinical judgment
- •28.History of thrombotic events
- •29.History or evidence of cardiac conditions including congestive cardiac failure leading to marked limitation on physical activity, or inability to pe
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