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

• Status: Not yet recruiting
• Trial end date: 2022-06-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz

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