Neovascular Age-related Macular Degeneration (nAMD)
Conditions
Keywords
Open label study,, intravitreal injection,, biosimilar,, aflibercept,, vial kit
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.
Interventions
DRUGSOK583A1
SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)
Sponsors
Sandoz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ocular Treatment Emergent Adverse Events | 31 days | Number of participants with ocular treatment emergent adverse events were reported. |
| Number of Participants With Non-ocular Treatment Emergent Adverse Events | 31 days | Number of participants with non-ocular treatment emergent adverse events were reported. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 5 study sites in the USA.
Participants by arm
| Arm | Count |
|---|---|
| SOK583A1 40 mg/mL SOK583A1 was provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL) | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | SOK583A1 40 mg/mL |
|---|---|
| Age, Continuous | 80.9 years STANDARD_DEVIATION 8.45 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 36 |
| other Total, other adverse events | 17 / 36 |
| serious Total, serious adverse events | 2 / 36 |
Outcome results
Primary
Number of Participants With Non-ocular Treatment Emergent Adverse Events
Number of participants with non-ocular treatment emergent adverse events were reported.
Time frame: 31 days
Population: Full analysis set (FAS): FAS included all participants who received an injection of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOK583A1 40 mg/mL | Number of Participants With Non-ocular Treatment Emergent Adverse Events | 3 Participants |
Primary
Number of Participants With Ocular Treatment Emergent Adverse Events
Number of participants with ocular treatment emergent adverse events were reported.
Time frame: 31 days
Population: Full analysis set (FAS): FAS included all participants who received an injection of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOK583A1 40 mg/mL | Number of Participants With Ocular Treatment Emergent Adverse Events | 16 Participants |