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

Study results available
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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

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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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282004 on ClinicalTrials.gov