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Monoclonal Antibodies

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit

Phase 3
Waitlist Available
Research Sponsored by Sandoz
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 31 days
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial involves giving a single injection of SOK583A1 to patients with nAMD who are already receiving similar eye treatments. The goal is to control the disease by stopping harmful blood vessel growth in the eye. SOK583A1 is a new treatment for nAMD, aiming to reduce the number of treatments needed by providing lasting benefits.

Eligible Conditions
  • Macular Degeneration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 31 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Non-ocular Treatment Emergent Adverse Events
Number of Participants With Ocular Treatment Emergent Adverse Events

Side effects data

From 2022 Phase 3 trial • 36 Patients • NCT05282004
42%
Intraocular pressure increased
6%
Conjunctival haemorrhage
3%
COVID-19
3%
Cystitis
3%
Arthralgia
3%
Vitreous floaters
100%
80%
60%
40%
20%
0%
Study treatment Arm
SOK583A1 40 mg/mL

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SOK583A1Experimental Treatment1 Intervention
SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SOK583A1
2022
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

SandozLead Sponsor
143 Previous Clinical Trials
26,239 Total Patients Enrolled
2 Trials studying Macular Degeneration
515 Patients Enrolled for Macular Degeneration
~10 spots leftby Dec 2025
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