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

• Status: Not yet recruiting
• Trial end date: 2022-05-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open label Phase IIIb study to evaluate the safety of use of a Prefilled syringe (PFS) containing SOK583A1 (40 mg/mL) and to support the collection of observations of the PFS use for intravitreal injection, when utilized by qualified ophthalmologists, who follow the Instructions for Use (IFU) appropriately to prepare and administer Intravitreal (IVT) injections to patients, suffering from nAMD.

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

Details

• Lead Sponsor: Sandoz
• Treatments: Aflibercept

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 antiglaucomatous 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

• Pregnant or nursing (lactating) women or women of child-bearing potential (WOCBP) is defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization at Baseline, unless they are using highly effective methods of contraception during dosing of study treatment.

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment. Highly effective contraception methods include:

• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.

• Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patients.

• Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception.