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Monoclonal Antibodies

SOK583A1 (40 mg/mL) for Age-Related Macular Degeneration (Mylight Trial)

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 baseline (pre-dose) and 24 hours after the first injection (day 2) and third injection (day 58)
Awards & highlights

Mylight Trial Summary

This trial is being conducted to compare the efficacy, safety, and immunogenicity of SOK583A1 to Eylea EU in patients with nAMD.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

Mylight Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-dose) and 24 hours after the first injection (day 2) and third injection (day 58)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-dose) and 24 hours after the first injection (day 2) and third injection (day 58) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best-Corrected Visual Acuity (BCVA) Will be Assessed Using the ETDRS Testing Charts at an Initial Distance of 4 Meters. The Change From Baseline in BCVA in Letters is Defined as Difference Between BCVA Score Between Week 8 and Baseline.
Secondary outcome measures
Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity
Similarity Between SOK583A1 and Eylea EU in Terms of Safety
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU
+2 more
Other outcome measures
Analysis Systemic VEGF Concentrations in Patients Treated With Aflibercept

Side effects data

From 2023 Phase 3 trial • 485 Patients • NCT04864834
10%
Neovascular age-related macular degeneration
8%
COVID-19
5%
Hypertension
5%
Visual acuity reduced
2%
Atrial fibrillation
1%
Cerebral infarction
1%
Coronary artery stenosis
1%
Retinal haemorrhage
1%
Femur fracture
1%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
SOK583
Eylea EU

Mylight Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SOK583A1 (40 mg/mL)Experimental Treatment1 Intervention
Intravitreal (IVT) administration of 2 mg of SOK583A1 in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48.
Group II: Eylea EU (40 mg/mL)Active Control1 Intervention
IVT administration of 2 mg of Eylea EU in the study eye, every 4 weeks (q4w) at Baseline, Week 4 and Week 8, and thereafter every 8 weeks (q8w) at week 16, 24, 32, 40 and 48. EU: European
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SOK583A1 (40 mg/mL)
2022
Completed Phase 3
~520

Find a Location

Who is running the clinical trial?

SandozLead Sponsor
142 Previous Clinical Trials
26,072 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main conditions that SOK583A1 (40 mg/mL) is used to treat?

"The most common treatment for wet age-related macular degeneration (wamd) is SOK583A1 (40 mg/mL). However, this medication can also be helpful in managing other eye conditions like macular edema, diabetic macular edema (dme), and regular old macular degeneration."

Answered by AI

Does SOK583A1 (40 mg/mL) have dangerous side effects?

"SOK583A1 (40 mg/mL) is a Phase 3 trial drug, meaning that while there is some efficacy data, multiple rounds of safety testing have been completed. Our team rates the safety as a 3."

Answered by AI

Are there other publications which touch upon SOK583A1 (40 mg/mL)?

"SOK583A1 (40 mg/mL) was first researched in 2013 at Massachusetts General Hospital. So far, there have been a total of 228 completed clinical trials. As of now, 51 live clinical trials are underway; a majority of these studies taking place in Poway, California."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I wish to preserve the vision that I have now. I am desperate to maintain the vision that I currently have.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration
2021. "Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04864834.
~124 spots leftby Apr 2025
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