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

Primary Purpose

Neovascular Age-related Macular Degeneration (nAMD)

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

SOK583A1

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (nAMD) focused on measuring Open label study,, intravitreal injection,, biosimilar,, aflibercept,, vial kit

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sandoz Investigational Site
Sandoz Investigational Site
Sandoz Investigational Site
Sandoz Investigational Site
Sandoz Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOK583A1

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Ocular Treatment Emergent Adverse Events

Number of participants with ocular treatment emergent adverse events were reported.

Number of Participants With Non-ocular Treatment Emergent Adverse Events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05282004

First Posted

March 7, 2022

Last Updated

April 17, 2023

Sponsor

Sandoz

1. Study Identification

Unique Protocol Identification Number

NCT05282004

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

May 16, 2022 (Actual)

Primary Completion Date

September 7, 2022 (Actual)

Study Completion Date

September 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sandoz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

Detailed Description

Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea USPI, 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 routine treatment scheme.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular Age-related Macular Degeneration (nAMD)

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOK583A1

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SOK583A1

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Ocular Treatment Emergent Adverse Events

Description

Number of participants with ocular treatment emergent adverse events were reported.

Time Frame

31 days

Title

Number of Participants With Non-ocular Treatment Emergent Adverse Events

Description

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

Time Frame

31 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Sandoz Investigational Site

City

Poway

State/Province

California

ZIP/Postal Code

92064

Country

United States

Facility Name

Sandoz Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Sandoz Investigational Site

City

Oak Forest

State/Province

Illinois

ZIP/Postal Code

60452

Country

United States

Facility Name

Sandoz Investigational Site

City

Liverpool

State/Province

New York

ZIP/Postal Code

13088

Country

United States

Facility Name

Sandoz Investigational Site

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24502

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

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

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