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

NCT05282004 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CSOK583A12303
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

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.

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Keywords

Open label study,; intravitreal injection,; biosimilar,; aflibercept,; vial kit

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SOK583A1

EXPERIMENTAL

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

Interventions

SOK583A1 DRUG

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

SOK583A1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sandoz: lead

Study Sites (5)

Sandoz Investigational Site

Poway, California, 92064, United States

Location

Sandoz Investigational Site

Marietta, Georgia, 30060, United States

Location

Sandoz Investigational Site

Oak Forest, Illinois, 60452, United States

Location

Sandoz Investigational Site

Liverpool, New York, 13088, United States

Location

Sandoz Investigational Site

Lynchburg, Virginia, 24502, United States

Location

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: May 16, 2022
• Primary Completion: September 7, 2022
• Study Completion: September 7, 2022
• Last Updated: May 10, 2023
• Results First Posted: May 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (5)