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

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 Vial Kit

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration (nAMD)
• Intervention / Treatment: Drug: SOK583A1

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Poway, California, United States, 92064
      • Sandoz Investigational Site
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Sandoz Investigational Site
  • Illinois
    • Oak Forest, Illinois, United States, 60452
      • Sandoz Investigational Site
  • New York
    • Liverpool, New York, United States, 13088
      • Sandoz Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Sandoz Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOK583A1; SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)	Drug: SOK583A1; SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)

What is the study measuring?

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.	31 days
Number of Participants With Non-ocular Treatment Emergent Adverse Events	Number of participants with non-ocular treatment emergent adverse events were reported.	31 days

Collaborators and Investigators

• Sponsor: Sandoz

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Open label study,; intravitreal injection,; biosimilar,; aflibercept,; vial kit
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: CSOK583A12303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No