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

Neovascular Age-related Macular Degeneration (nAMD) Clinical Trial

Official title:

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 Prefilled Syringe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161806
• Other study ID #: CSOK583A12304
• Status: Completed
• Phase: Phase 3
• Start date: March 11, 2022
• Est. completion date: May 4, 2022

Study information

• Verified date: October 2022
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Screening and Baseline could be performed on the same day.

Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea US PI, 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 individual dosing schedule.

Demonstration of the safe use of the PFS containing SOK583A1 was based on the performance of at least 3 different ophthalmologist teams.

Follow-up visits were performed on-site on Day 8 (±2 days) and on Day 31 (+4 days - end of study visit). Subjects participated for 30 to 34 days in the study including Baseline and treatment on Day 1 (Screening and Baseline could be performed on the same day) and the last safety follow-up on Day 31 (a time window of plus 4 days was allowed for the last safety follow-up).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration (nAMD)
• Wet Macular Degeneration

Intervention

Drug:
• SOK583A1 (40 mg/mL)
SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration

Device:
• Prefilled Syringe (PFS)
Prefilled Syringe (PFS)

Locations

Country	Name	City	State
United States	Sandoz Investigational Site	Liverpool	New York
United States	Sandoz Investigational Site	Marietta	Georgia
United States	Sandoz Investigational Site	Oak Forest	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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