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

NCT ID: NCT05282004

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2022-09-07

Brief 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.

Detailed Description

Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea USPI, 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 routine treatment scheme.

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOK583A1

SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)

Group Type: EXPERIMENTAL

SOK583A1

Intervention Type: DRUG

SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)

Interventions

SOK583A1

SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sandoz Investigational Site

Poway, California, United States

Sandoz Investigational Site

Marietta, Georgia, United States

Sandoz Investigational Site

Oak Forest, Illinois, United States

Sandoz Investigational Site

Liverpool, New York, United States

Sandoz Investigational Site

Lynchburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CSOK583A12303

Identifier Type: -

Identifier Source: org_study_id