Neovascular Age-related Macular Degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Sponsors
SamChunDang Pharm. Co. Ltd.
Eligibility
Sex/Gender
All
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 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. 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
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-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 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 extraocular inflammation in either eye or intraocular inflammation in study 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 (eg, co-existence of RVO, 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 24. Uncontrolled hypertension defined as systolic blood pressure (BP) >180 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 eve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: • 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;Primary end point(s): Primary endpoint: • Change from baseline in BCVA as measured by ETDRS letters score or 2702 charts.;Timepoint(s) of evaluation of this end point: at Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • Change from baseline in best corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score or 2702 charts at Week 52 • Change from baseline in CRT at Week 8 as assessed by optical coherence tomography (OCT) • Change from baseline in central retinal thickness (CRT) at Week 52 as assessed by OCT • Change from baseline in choroidal neovascularization (CNV) area at Week 8 • Change from baseline in CNV area at Week 52 • Percentage of subjects who gain at least 15 letters in BCVA as measured by ETDRS letter score or 2702 charts compared with baseline at Week 8 • Percentage of subjects who gain at least 15 letters in BCVA as measured by ETDRS letter score or 2702 charts compared with baseline at Week 52.;Timepoint(s) of evaluation of this end point: at week 8, at week 52 | — |
Countries
Australia, Bulgaria, Czech Republic, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Poland, Russian Federation, Slovakia, Spain, United States
Contacts
Public ContactClinical Development
SamChunDang Pharm. Co. Ltd
Outcome results
None listed