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

ClinicalTrials.gov Identifier: NCT05282004

Novartis Reference Number: CSOK583A12303

Last Update: Aug 01, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 
Neovascular Age-related Macular Degeneration (nAMD)
Phase 
Phase 3
Overall status 
Recruiting
Start date 
May 16, 2022
Completion date 
Aug 09, 2022
Gender 
All
Age(s)
50 Years and older (Adult, Older Adult)

Interventions

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)

Eligibility Criteria

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 Locations

United States
Sandoz Investigational Site
Recruiting
Marietta, 30060
Georgia
United States
Sandoz Investigational Site
Recruiting
Oak Forest, 60452
Illinois
United States
Sandoz Investigational Site
Recruiting
Liverpool, 13088
New York
United States

Contacts

Name: 
Sandoz
Phone: 

Have a question?

Call 1-888-669-6682 or email novar[email protected]