Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema, Central Retinal Vein Occlusion With Macular Edema, Myopic Choroidal Neovascularization
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 trial participants with nAMD, Macular Oedema Secondary to RVO, or Myopic Choroidal Neovascularization (mCNV).
Detailed description
HCPs will prepare and administer intravitreal injections of SB11 0.5 mg delivered via PFS to trial participants on Day 1 and safety follow-up will be assessed until Day 7.
Interventions
COMBINATION_PRODUCTSB11 PFS
SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for intravitreal 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
Only one eye will be selected as the study eye. Key Inclusion Criteria: * Neovascular AMD, macular oedema secondary to RVO, or mCNV in the study eye * Study eye deemed to be indicated for ranibizumab IVT therapy at the discretion of the ophthalmologist (e.g., retina specialist) Key
Exclusion criteria
* BCVA of the level of Finger Count or worse \[e.g., 0 letter reading using Early Treatment Diabetic Retinopathy Study (ETDRS) chart\] in one or both eyes at Screening or at Day 1 * Treatment with any IVT injection within the 30 days prior to Day 1 in the study eye * Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1 * Treatment with systemic (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1 * Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Successful Task Completions on All of the 12 tasks | Day 1 | A total of 12 tasks were evaluated, and the percentage of HCPs' successful completions on all of the 12 tasks was measured. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Successful Completion on Each of 12 tasks | Day 1 |
| Incidence of AEs and serious adverse events (SAEs) | From Day 1 to Day 7 |
| Change from baseline in Best Corrected Visual Acuity (BCVA) | From Day 1 to Day 7 |
Countries
Poland
Outcome results
None listed