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Anti-VEGF
A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)
Phase 3
Waitlist Available
Research Sponsored by Sam Chun Dang Pharm. Co. Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 8, 20, 36 and 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing SCD411, a new drug similar to Eylea, in adults with wet age-related macular degeneration (AMD). Wet AMD causes vision loss due to abnormal blood vessels growing and leaking in the eye. SCD411 works by blocking a protein that causes these harmful blood vessels to grow and leak. The study will check if SCD411 is as safe and effective as Eylea.
Eligible Conditions
- Wet AMD
- Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 4, 8, 20, 36 and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 8, 20, 36 and 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in BCVA (Best Corrected Visual Acuity)
Secondary study objectives
Percentage of Subjects With Anti-SCD411 Antibodies
Side effects data
From 2022 Phase 3 trial • 576 Patients • NCT044804637%
Neovascular age-related macular degeneration
6%
COVID-19
4%
Visual acuity reduced
4%
Hypertension
3%
Urinary tract infection
3%
Back pain
2%
Nasopharyngitis
2%
Osteoarthritis
2%
Type 2 diabetes mellitus
2%
Abdominal pain
2%
Vitreous floaters
2%
Intraocular pressure increased
2%
Dry eye
2%
Conjunctivitis
1%
Cataract
1%
Visual impairment
1%
Atrial fibrillation
1%
Pneumonia
1%
Dyspepsia
1%
Lacrimation increased
1%
Tooth abscess
1%
Subretinal fluid
1%
Age-related macular degeneration
1%
Posterior capsule opacification
1%
Punctate keratitis
1%
Arthralgia
1%
Sleep apnoea syndrome
1%
Eye pain
1%
Gastroenteritis
1%
Pain in extremity
1%
Sinusitis
1%
Retinal pigment epithelial tear
1%
Conjunctival haemorrhage
1%
Dizziness
1%
Headache
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
SCD411
Aflibercept
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SCD411Experimental Treatment1 Intervention
Group II: AfliberceptActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SCD411
2020
Completed Phase 3
~580
Find a Location
Who is running the clinical trial?
Sam Chun Dang Pharm. Co. Ltd.Lead Sponsor
Byung Jhip HaStudy DirectorSam Chun Dang Pharm. Co. Ltd.