Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe

Study Overview
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Brief Summary
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This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.

Detailed Description
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This was an open-label, single arm, multicenter, Phase IIIb study in subjects with nAMD, eligible for Intravitreal (IVT) aflibercept treatment. Screening and Baseline could be performed on the same day. Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea US PI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their individual dosing schedule. Demonstration of the safe use of the PFS containing SOK583A1 was based on the performance of at least 3 different ophthalmologist teams. Follow-up visits were performed on-site on Day 8 (±2 days) and on Day 31 (+4 days - end of study visit). Subjects participated for 30 to 34 days in the study including Baseline and treatment on Day 1 (Screening and Baseline could be performed on the same day) and the last safety follow-up on Day 31 (a time window of plus 4 days was allowed for the last safety follow-up).

Official Title
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An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Prefilled Syringe

Conditions
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Neovascular Age-related Macular Degeneration (nAMD)

Intervention / Treatment
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* Drug: SOK583A1 (40 mg/mL)
* Device: Prefilled Syringe (PFS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥ 50 years of age at baseline Subjects diagnosed with nAMD (uni- or bilateral) Subjects already under IVT Eylea treatment (last injection of the induction period or maintenance phase) Exclusion Criteria: Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator's judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 26 mmHg, despite treatment with anti-glaucomatous medication) History of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of investigational product Visual Acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted level of legal blindness Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening) Subjects who do not comply with the local COVID-19 regulations of the study site

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOK583A1 (40 mg/mL)<br>participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study | Drug: SOK583A1 (40 mg/mL)<br>* SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration<br>* Other names: aflibercept;Device: Prefilled Syringe (PFS)<br>* Prefilled Syringe (PFS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Ocular Treatment Emergent Adverse Events | Number of participants with ocular treatment emergent adverse events were reported. | throughout the study, approximately 31 days | 
| Number of Participants With Non-ocular Treatment Emergent Adverse Events | Number of participants with non ocular Treatment emergent adverse events were reported. | throughout the study, approximately 31 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open label study,, intravitreal injection,, biosimilar,, aflibercept,, PFS