Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients With Neovascular Age-related Macular Degeneration

Phase 3

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Biological: Eylea EU (40 mg/mL); Biological: SOK583A1 (40 mg/mL)

• Registration Number: NCT04864834
• Lead Sponsor: Sandoz

Brief Summary

Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD.

The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?

Detailed Description

BCVA: Best-Corrected Visual Acuity Eylea EU: Europe-authorized Eylea® nAMD: Neovascular Age-related Macular Degeneration VEGF: Vascular Endothelium Growth Factor

Study Timeline

• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-29
• Study Start: 2021-05-12
• Primary Completion: 2022-07-07
• Study Completion: 2023-05-10
• Disposition First Submitted: 2023-06-13
• Status Verified: 2023-07
• Results First Submitted: 2024-01-25
• Results First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Results First Posted: 2024-03-26
• Disposition First Posted: 2024-03-26
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eylea EU (40 mg/mL)	Eylea EU (40 mg/mL)	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
SOK583A1 (40 mg/mL)	SOK583A1 (40 mg/mL)	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.

Primary Outcome Measures

Name	Time	Method
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.	Change from baseline in mean BCVA score at Week 8	The primary aim of the study is to demonstrate equivalence of change in BCVA score from Baseline at Week 8 between participants with nAMD treated with SOK583A1 and participants treated with Eylea EU. The primary analysis will be performed on the Per-Protocol Set (PPS), which is the most appropriate analysis set to use when testing for equivalence.; ETDRS: Early Treatment Diabetic Retinopathy Study EU: European

Secondary Outcome Measures

Name	Time	Method
Similarity Between SOK583A1 and Eylea EU in Terms of Immunogenicity	Week 52	Development of binding and neutralizing Anti-drug antibodies (ADAs) up to Week 52
Systemic Exposure to SOK583A1 and Eylea EU in Participants of the Pharmacokinetic (PK) Assessment	Baseline (pre-dose) and 24 hours after the first injection (day 2) and third injection (day 58)	Aflibercept concentration assessments at Baseline (pre-dose) and 24 hours after the first and third injections
Similarity in the Anatomical Outcome Between SOK583A1 and Eylea EU	Week 8 and 52	Mean change of CNV lesion size using FA from Screening to Week 8 and 52; CNV: Choroidal neovascularization FA: Fundus Angiography
Similarity Between SOK583A1 and Eylea EU in Terms of Safety	52 weeks	Number and proportion of subjects with ocular and non-ocular Adverse Events (AEs) over 52 weeks including serious AEs, regardless of relationship to study treatment
Similarity of Efficacy Between SOK583A1 and Eylea EU in Terms of BCVA	Week 24 and 52	Mean change from Baseline in BCVA score using EDTRS testing charts at Week 24 and 52

Trial Locations

Locations (1)

Sandoz Investigational Site; 🇪🇸 Zaragoza, Spain