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

An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Subjects With Neovascular Age-Related Macular Degeneration or Macular Oedema Secondary to Retinal Vein Occlusion

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema; Retinal Vein Occlusion; Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Combination product: SB11 PFS

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Katowice, Poland
    • SB Investigational Site
  • Kraków, Poland
    • SB Investigational Site
  • Olsztyn, Poland
    • SB Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SB11 PFS; Subjects received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.	Combination product: SB11 PFS; SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for ITV injection; Other Names: Ranibizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day 1

Collaborators and Investigators

• Sponsor: Samsung Bioepis Co., Ltd.
• Investigators: Principal Investigator: Piotr Oleksy, M.D., Centrum Medyczne Dietla 19 Krakow

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Embolism and Thrombosis; Retinal Diseases; Retinal Degeneration; Venous Thrombosis; Thrombosis; Edema; Macular Degeneration; Macular Edema; Wet Macular Degeneration; Retinal Vein Occlusion; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: SB11-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes