Evaluation of SB11 Pre-Filled Syringe Usability in Patients with Neovascular AMD, Macular Edema Secondary to RVO, or Myopic Choroidal Neovascularization

Trial ID: 2025-520599-24-00
Protocol: SB11-2002
Sponsor: Samsung Bioepis Co. Ltd.

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Diseases & Conditions

Macular oedema Neovascular age-related macular degeneration Choroidal neovascularisation

Objectives

The primary objective of this study is to assess the ability of **Healthcare Professionals** (HCPs) to follow the instructions for use (IFU) to prepare and administer SB11 pre-filled syringe (PFS) intravitreal injection to trial participants. This is clinically relevant as it evaluates the practical usability of the SB11 PFS, ensuring that HCPs can effectively and safely administer the treatment, which is crucial for patient safety and treatment efficacy.

The secondary objective of this study is to evaluate the safety and efficacy of SB11 PFS in trial participants with **neovascular Age-Related Macular Degeneration** (AMD), **macular oedema secondary to Retinal Vein Occlusion** (RVO), or **myopic Choroidal Neovascularization** (mCNV). This assessment is important to determine the therapeutic benefits and potential risks associated with the use of SB11 PFS in these specific ocular conditions.

Participants

The clinical trial involves participants diagnosed with **Neovascular Age-Related Macular Degeneration (AMD)**, Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV). The study population includes both male and female subjects aged 18 years and older. Participants are required to have a study eye indicated for ranibizumab intravitreal therapy, as determined by an ophthalmologist. The trial does not include a vulnerable population. Participants must be willing and able to attend all scheduled visits and assessments. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations include the use of appropriate contraception methods for females of childbearing potential and their partners, or males with partners of childbearing potential, from screening until three months post-injection. The trial population was selected based on specific medical conditions and the ability to comply with study requirements.

Plans and Procedures

The clinical trial is designed as an **open-label**, single-group, single-dose study to evaluate the usability of a pre-filled syringe containing **ranibizumab** for intravitreal injection in participants with **Neovascular Age-Related Macular Degeneration (AMD)**, **Macular Oedema Secondary to Retinal Vein Occlusion (RVO)**, or **Myopic Choroidal Neovascularization (mCNV)**. The primary objective is to assess the ability of healthcare professionals to follow the instructions for use to prepare and administer the injection. The trial is categorized as a Phase 4 study and is not considered low intervention. The estimated duration of the trial is from June 13, 2025, to August 2, 2025.

Participants will be involved in the study for a short duration, with the primary endpoint being the percentage of successful task completions on all 12 tasks on Day 1. Secondary endpoints include the usability endpoint, which measures the percentage of successful completion on each task, the safety endpoint, which records the incidence of adverse events and serious adverse events from Day 1 to Day 7, and the efficacy endpoint, which evaluates the change from baseline in best-corrected visual acuity (BCVA) at Day 7.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is confirmed based on criteria such as age, medical condition, and willingness to comply with study procedures. Participants must have a study eye indicated for ranibizumab therapy and meet specific contraceptive requirements if applicable. The study involves a single administration of the investigational product, followed by a follow-up visit on Day 7 to assess safety and efficacy outcomes. The end-of-study visit coincides with the Day 7 follow-up.

Participant involvement is expected to last approximately one week, from the initial screening to the final follow-up visit. Conditions that may lead to early termination from the study include the occurrence of serious adverse events or the participant's inability to comply with study procedures. The study is conducted under strict adherence to ethical guidelines, ensuring that all participants provide informed consent before any study-related procedures are initiated.

Treatment

The clinical trial involves the administration of **Byooviz 10 mg/ml solution for injection**, which contains the active substance **ranibizumab**. This experimental medication is presented in a pre-filled syringe and is intended for **intravitreal use**. The pharmaceutical form is a solution for injection, and the dosage is set at a maximum of 0.5 mg per administration. The administration is a single-dose regimen, with the treatment period limited to one day. The pre-filled syringe has been newly developed as an alternative to the vial presentation previously approved in the EU. The study aims to evaluate the usability of this pre-filled syringe in trial participants diagnosed with Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV).

There are no non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, included in this study. The primary objective is to assess the ability of healthcare professionals to follow the instructions for use to prepare and administer the SB11 PFS intravitreal injection. Participant compliance will be monitored by ensuring adherence to the single-dose administration protocol. The trial does not involve any pediatric formulations, and the product is not classified as an orphan drug. The study is conducted under the sponsorship of Samsung Bioepis NL B.V., and the product is authorized for use in the European Union.

Efficacy

Efficacy in this clinical trial will be assessed through the evaluation of the **Best Corrected Visual Acuity (BCVA)**. The primary efficacy endpoint is the change from baseline in BCVA at Day 7. This parameter will be measured to determine the effectiveness of the investigational product, SB11, in trial participants with Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV). The BCVA will be assessed using standardized ophthalmological methods to ensure accuracy and consistency in the data collected.

Inclusion and Exclusion Criteria

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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)
Aged 18 years and older at the time of signing the informed consent form (ICF)
Written ICF must be obtained from the trial participant prior to any study-related procedure (if the trial participant 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
Non-childbearing potential female (e.g., having congenital or acquired condition that prevents childbearing, having history of hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion) or postmenopausal [defined as amenorrhoea of at least 12 months without an alternative medical cause prior to the time of ICF signing] OR Childbearing potential female trial participants or male trial participants with their (respectively male or female) partners who agree to use at least 2 forms of appropriate contraception method (e.g., established use of oral, injected, intravaginal, transdermal or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner or physical barrier [Note: Female condom and male condom should not be used together]) or 1 highly effective contraception method (e.g., sexual abstinence) from Screening until 3 months after the IVT injection of investigational product (IP). Note: Vasectomy will be allowed for male trial participants and female trial participants of childbearing potential with a sole vasectomised male partner. Vasectomised trial participants or partners should be medically confirmed for sterilisation. True abstinence alone will be allowed if this is in line with the preferred and usual lifestyle of the trial participant, or for trial participants who do not have a partner. Periodic abstinence (e.g., calendar, ovulation, symptothermal postovulation methods) and withdrawal are not acceptable methods of contraception.

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Exclusion Criteria

Best Corrected Visual Acuity (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
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 IVT 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 IVT injection or intraocular procedures in either eye
History of massive subconjunctival haemorrhages of concern reported by the trial participant after an IVT 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 IVT 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 (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) 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
Known history of intolerance, reaction to prior biological therapies
Pregnant or lactating women at Screening or at Day 1