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

NCT05161806 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: CSOK583A12304
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Keywords

Open label study,; intravitreal injection,; biosimilar,; aflibercept,; PFS

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.

  throughout the study, approximately 31 days

• Number of Participants With Non-ocular Treatment Emergent Adverse Events

  Number of participants with non ocular Treatment emergent adverse events were reported.

  throughout the study, approximately 31 days

Study Arms (1)

SOK583A1 (40 mg/mL)

EXPERIMENTAL

participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study

Drug: SOK583A1 (40 mg/mL); Device: Prefilled Syringe (PFS)

Interventions

SOK583A1 (40 mg/mL) DRUG

SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration

Also known as: aflibercept

SOK583A1 (40 mg/mL)

Prefilled Syringe (PFS) DEVICE

Prefilled Syringe (PFS)

SOK583A1 (40 mg/mL)

Eligibility Criteria

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

You may qualify if:

• Subjects ≥ 50 years of age at baseline
• Subjects diagnosed with nAMD (uni- or bilateral)
• Subjects already under IVT Eylea treatment (last injection of the induction period or maintenance phase)

You may not qualify if:

• Active 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 intraocular pressure (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
• 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)
• Subjects who do not comply with the local COVID-19 regulations of the study site

Sponsors & Collaborators

• Sandoz: lead

Study Sites (3)

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

MeSH Terms

Interventions

aflibercept

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

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: December 15, 2021
• First Posted: December 17, 2021
• Study Start: March 11, 2022
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: November 18, 2022
• Results First Posted: November 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

US (3)