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）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 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 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
- •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
- •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.
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-vascular endothelial growth factor (VEGF) agents in the both eyes (ie, completely treatment naïve subjects only to be included)
- •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. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible CNV)
- •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 (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
- •12. Active extraocular inflammation in either eye or intraocular inflammation in study eye
- •13. History of any vitreous hemorrhage in the study eye within 4 weeks 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, diabetic macular edema, 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
- •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.
- •20. Presence of aphakia in the study eye.
- •21. History of glaucoma-filtering surgery within 3 months of Day 1 in the study eye. Anti-glaucoma 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 (eg, co-existence of retinal vein occlusion, radiation retinopathy, dia
研究者
相似试验
进行中（未招募）
1 期
A clinical study to determine if a potential new drug (SCD411) is similar to the marketed product Eylea® in the efficacy, is safe and similar tolerable and distributed, by testing its effect on the body in patients with Neovascular Age-related Macular DegeneratioEUCTR2019-004132-37-ITSam Chun Dang Pharm. Co. Ltd560
进行中（未招募）
1 期
A clinical study to determine if a potential new drug (SCD411) is similar to the marketed product Eylea® in the efficacy, is safe and similar tolerable and distributed, by testing its effect on the body in patients with Neovascular Age-related Macular Degeneratioeovascular Age-related Macular DegenerationMedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2019-004132-37-HUSamChunDang Pharm. Co. Ltd.560
进行中（未招募）
1 期
A clinical study to determine if a potential new drug (SCD411) is similar to the marketed product Eylea® in the efficacy, is safe and similar tolerable and distributed, by testing its effect on the body in patients with Neovascular Age-related Macular Degeneratioeovascular Age-related Macular DegenerationMedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2019-004132-37-CZSamChunDang Pharm. Co. Ltd.560
进行中（未招募）
1 期
A clinical study to determine if a potential new drug (SCD411) is similar to the marketed product Eylea® in the efficacy, is safe and similar tolerable and distributed, by testing its effect on the body in patients with Neovascular Age-related Macular Degeneratioeovascular Age-related Macular DegenerationMedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2019-004132-37-BGSamChunDang Pharm. Co. Ltd.573
进行中（未招募）
1 期
A clinical study to determine if a potential new drug (SCD411) is similar to the marketed product Eylea® in the efficacy, is safe and similar tolerable and distributed, by testing its effect on the body in patients with Neovascular Age-related Macular DegeneratioEUCTR2019-004132-37-PLSamChunDang Pharm. Co. Ltd.560