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

Sponsor

Sandoz (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05282004

Collaborator

(none)

Enrollment

Locations

Arm

2.8

Anticipated Duration (Months)

12.7

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration (nAMD)	Drug: SOK583A1	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Vial Kit

Actual Study Start Date :

May 16, 2022

Anticipated Primary Completion Date :

Aug 9, 2022

Anticipated Study Completion Date :

Aug 9, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Number of ocular or non-ocular Adverse events [throughout the study, approximately 31 days]
Evaluate the safety of use of a vial kit containing SOK583A1 (40 mg/mL) in patients requiring IVT aflibercept treatment (capturing the AEs)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sandoz Investigational Site	Marietta	Georgia	United States	30060
2	Sandoz Investigational Site	Oak Forest	Illinois	United States	60452
3	Sandoz Investigational Site	Liverpool	New York	United States	13088