Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit
NCT05282004 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2023-05-10
Summary
This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.
Conditions
- Neovascular Age-related Macular Degeneration (nAMD)
Interventions
- DRUG
-
SOK583A1
SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-16
- Primary Completion
- 2022-09-07
- Completion
- 2022-09-07
- FDA Drug
- Yes
Countries
- United States
Study Locations
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