Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: SCD411: 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
Sponsors
SamChunDang Pharm Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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.Timepoint: • Change from baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts at Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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 - To compare the immunogenicity of SCD411 and aflibercept by presenting information of the development of anti-SCD411 antibodies.Timepoint: Safety endpnts include AEs, vital signs, and lab assessments up to Wk 52. Efficacy endpoints include following: Change from baseline of BCVA, CRT and CNV. Immunogenicity endpoints include the evaluation of development of anti-SCD411 antibodies using blood samples taken at Baseline, at Wks 4, 8, 20, 36, and 52 | — |
Countries
Australia, Bulgaria, Czech Republic, Hungary, India, Israel, Italy, Japan, Latvia, Poland, Republic of Korea, Russian Federation, Slovakia, Spain, United States of America
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
Outcome results
None listed