Neovascular Age-related Macular Degeneration (nAMD)
Conditions
Keywords
Open label study,, intravitreal injection,, biosimilar,, aflibercept,, PFS
Brief summary
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
Detailed 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).
Interventions
SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration
DEVICEPrefilled Syringe (PFS)
Prefilled Syringe (PFS)
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ocular Treatment Emergent Adverse Events | throughout the study, approximately 31 days | Number of participants with ocular treatment emergent adverse events were reported. |
| Number of Participants With Non-ocular Treatment Emergent Adverse Events | throughout the study, approximately 31 days | Number of participants with non ocular Treatment emergent adverse events were reported. |
Countries
United States
Participant flow
Recruitment details
Study was conducted in 3 study sites in the US. All 3 sites screened and treated participants.
Pre-assignment details
All enrolled participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL).
Participants by arm
| Arm | Count |
|---|---|
| SOK583A1 (40 mg/mL) participants received a single dose of 2 mg SOK583 in 0.05 mL (40 mg/mL) and completed the study | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | SOK583A1 (40 mg/mL) |
|---|---|
| Age, Continuous | 79.4 Years STANDARD_DEVIATION 7.41 |
| Race/Ethnicity, Customized White | 30 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 |
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: throughout the study, approximately 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 | 1 Participants |
Primary
Number of Participants With Ocular Treatment Emergent Adverse Events
Number of participants with ocular treatment emergent adverse events were reported.
Time frame: throughout the study, approximately 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 | 2 Participants |