Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit
Condition: Neovascular Age-related Macular Degeneration (nAMD)
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: SOK583A1
Intervention description: SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Open label study,; intravitreal injection,; biosimilar,; aflibercept,; vial kit

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 50 years of age at baseline

          -  Patients diagnosed with nAMD (uni- or bilateral)

          -  Patients already under IVT Eylea treatment (last injection of the induction period or
             maintenance phase)

          -  Willing and able to comply with all study procedures, and be likely to complete the
             study

          -  Signed informed consent must be obtained before any assessment is performed

        Exclusion Criteria:

          -  Active, suspected 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 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

          -  Topical ocular corticosteroids administered for at least 30 consecutive days within 3
             months prior to screening

          -  Systemic treatment with long-acting corticosteroids (more than 10 mg prednisolone
             equivalent) within 3 months prior to screening Current or planned use of systemic
             medications known to be toxic to the lens, retina or optic nerve, including
             deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol

          -  Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug
             release device implantation (approved or investigational) in the study eye any time
             during the past 3 months

          -  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)

          -  Participants who do not comply with the local COVID-19 regulations of the study site