Macular Edema, Neovascular Age-related Macular Degeneration, Retinal Vein Occlusion
Conditions
Brief summary
This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.
Detailed description
This is an open-label, single group, single dose study in subjects with nAMD or Macular Oedema Secondary to RVO. Screening and Day 1 can be performed on the same day. Subjects will receive ITV injection of SB11 PFS (0.5 mg ranibizumab in 0.05 mL) on Day 1, and follow up visit will be made on Day 1 (+2).
Interventions
COMBINATION_PRODUCTSB11 PFS
SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Neovascular AMD or macular oedema secondary to RVO in the study eye * Study eye deemed to be indicated for ranibizumab ITV therapy at the discretion of the ophthalmologist (e.g., retina specialist) * Aged 18 years and older at the time of signing the informed consent form (ICF) * Written ICF must be obtained from the subject prior to any study-related procedure (if the subject cannot read ICF, an impartial witness will be present during the entire informed consent discussion) * Willingness and ability to undertake all scheduled visits and assessments
Exclusion criteria
* Best Corrected Visual Acuity (BCVA) of the level of Finger Count or worse \[i.e., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart\] in one or both eyes at Screening or at Day 1 * History of and/or current intraocular inflammation (any grading from trace and greater is excluded), including non-infectious uveitis, infectious uveitis, or scleritis, or history of sterile inflammatory reaction after the past ITV injections with any agent in either eye * Active or suspected infectious disease, or active disorder that preclude safe use of IP at the discretion of the Investigator, in either eye or adnexa of either eye at Screening or at Day 1 * History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after ITV injection or intraocular procedures in either eye * History of massive subconjunctival haemorrhages of concern reported by the subject after an ITV injection in either eye * Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1 * Treatment with any ITV injection within the 30 days prior to Day 1 in the study eye * Any invasive ocular surgery including retinal detachment surgery, long-acting ocular therapeutic agent/implant including corticosteroid, or ocular drug release device implant (approved or investigational) in the study eye within 90 days prior to Day 1 or planned intraocular surgery within next 28 days after Day 1 * Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1 * Treatment with any ocular IP in either eye within 90 days prior to Day 1 * Treatment with systemic anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1 * Receipt of any systemic (non-ocular) IP within 180 days prior to Day 1 * Use of therapies that are known to be toxic to ocular tissue within the 180 days prior to Day 1, including, but not limited to, deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, or ethambutol * Known ocular or non-ocular conditions that per the ophthalmologist (e.g., retina specialist) represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk * Uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg while sitting confirmed after repeated measurement) at Screening or Day 1 * Current systemic infectious disease or therapy for active infectious disease * Pregnant or lactating women at Screening or at Day 1 Note: Other Protocol Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Successful Task Completions | Day 1 | Total of 12 tasks were evaluated, and the percentage of HCP's successful task completions were measured. Participating HCPs were allotted sufficient time to review the instructions for use (IFU) before preparing and administering the ITV injection on Day 1. HCP participants did not receive any additional training for the SB11 PFS prior to or during the study. Percentage of successful task completions was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the primary endpoint was the percentage of successful tasks completion among total attempts in this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Successful Completion on Critical Tasks | Day 1 | Total of 6 tasks were considered as critical task, and the percentage of HCP's successful completion on critical tasks were evaluated. Percentage of successful task completions was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the secondary endpoint was the percentage of successful critical tasks (total of 6) completion among total attempts in this study. |
| Percentage of Successful Completion on Essential Tasks | Day 1 | Total of 6 tasks were considered as essential task, and the percentage of HCP's successful completion on essential tasks were evaluated. Percentage of successful task completions was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the secondary endpoint was the percentage of successful essential tasks (total of 6) completion among total attempts in this study. |
Countries
Poland
Participant flow
Pre-assignment details
34 subjects were enrolled for this study and 4 HCPs participated in this study.
Participants by arm
| Arm | Count |
|---|---|
| SB11 PFS Subjects received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.
SB11 PFS: SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | SB11 PFS |
|---|---|
| Age, Continuous | 74.1 years STANDARD_DEVIATION 7.45 |
| Main Indication Macular Oedema Secondary to RVO | 2 Participants |
| Main Indication Neovascular AMD | 32 Participants |
| 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 | 34 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 2 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Percentage of Successful Task Completions
Total of 12 tasks were evaluated, and the percentage of HCP's successful task completions were measured. Participating HCPs were allotted sufficient time to review the instructions for use (IFU) before preparing and administering the ITV injection on Day 1. HCP participants did not receive any additional training for the SB11 PFS prior to or during the study. Percentage of successful task completions was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the primary endpoint was the percentage of successful tasks completion among total attempts in this study.
Time frame: Day 1
Population: Overall, 4 participating HCPs performed tasks on 34 enrolled patients (a single PFS ITV injection per patient) leading to a total of 34 attempts for each tasks in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB11 PFS | Percentage of Successful Task Completions | Dispose product | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Open the carton | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Remove contents | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Peel the lid off the blister pack | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Carefully remove the PFS from the blister using aseptic technique | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Remove the syringe cap | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Attach a needle | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Remove the needle cap | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Set the dose | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Insert the needle into the injection site | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Press the plunger down to inject the medication | 100 Percentage of successful task completion |
| SB11 PFS | Percentage of Successful Task Completions | Remove the needle from the injection site | 100 Percentage of successful task completion |
Secondary
Percentage of Successful Completion on Critical Tasks
Total of 6 tasks were considered as critical task, and the percentage of HCP's successful completion on critical tasks were evaluated. Percentage of successful task completions was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the secondary endpoint was the percentage of successful critical tasks (total of 6) completion among total attempts in this study.
Time frame: Day 1
Population: Overall, 4 participating HCPs performed tasks on 34 enrolled patients (a single PFS ITV injection per patient) leading to a total of 34 attempts for each tasks in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SB11 PFS | Percentage of Successful Completion on Critical Tasks | 100 Percentage of successful task completion |
Secondary
Percentage of Successful Completion on Essential Tasks
Total of 6 tasks were considered as essential task, and the percentage of HCP's successful completion on essential tasks were evaluated. Percentage of successful task completions was used as the unit of measure, as one SB11 PFS administration procedure is consisted of 12 tasks and the secondary endpoint was the percentage of successful essential tasks (total of 6) completion among total attempts in this study.
Time frame: Day 1
Population: Overall, 4 participating HCPs performed tasks on 34 enrolled patients (a single PFS ITV injection per patient) leading to a total of 34 attempts for each tasks in this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SB11 PFS | Percentage of Successful Completion on Essential Tasks | 100 Percentage of successful task completion |