A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

Phase 2

Completed

• Conditions: Macular Edema; Neovascular Age-related Macular Degeneration; Retinal Vein Occlusion
• Interventions: Combination Product: SB11 PFS

• Registration Number: NCT06176963
• Lead Sponsor: Samsung Bioepis Co., Ltd.

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).

Study Timeline

• Study Start: 2023-11-21
• Primary Completion: 2023-11-30
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study Completion: 2023-12-12
• Study First Posted: 2023-12-20
• Results First Submitted: 2024-11-11
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Results First Posted: 2024-12-30
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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/Exclusion Criteria Apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SB11 PFS	SB11 PFS	Subjects received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

SB Investigational Site; 🇵🇱 Olsztyn, Poland