Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular AMD
NCT04058535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2022-01-20
Summary
To evaluate the safety, efficacy and pharmacokinetics of repeated intravitreal administration of ALT-L9 2 mg/50uL compared with Eylea in patients with neovascular Age-related macular degeneration.
Conditions
- Neovascular Age-related Macular Degeneration
Interventions
- BIOLOGICAL
-
Aflibercept
- BIOLOGICAL
-
ALT-L9
Aflibercept biosimilar
Sponsors & Collaborators
-
Alteogen, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-02-05
- Primary Completion
- 2020-12-22
- Completion
- 2020-12-22
Countries
- South Korea
Study Locations
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