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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520599-24-00 | EU Trial (CTIS) Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB11 PFS | Experimental | Trial participants received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB11 PFS | Combination Product | SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Successful Task Completions on All of the 12 tasks | A total of 12 tasks were evaluated, and the percentage of HCPs' successful completions on all of the 12 tasks was measured. | Day 1 |
| Measure | Description | 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) |
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Only one eye will be selected as the study eye.
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Krakow | Poland | ||||
| Research site |
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| From Day 1 to Day 7 |
| Olsztyn |
| Poland |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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