An open-label, single group, single-dose clinical study to evaluate the usability of the pre-filled syringe (PFS) of SB11 in trial participants with Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Samsung Bioepis Co. Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

27 Mar 2026 → 9 Apr 2026

Decision date (initial)

2025-06-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Samsung Bioepis Co., Ltd.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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 PFS intravitreal (IVT) injection to trial
participants.

Secondary objectives 1

1. The secondary objective of this study is to evaluate the safety and efficacy of SB11 PFS in trial participants with neovascular AMD, macular oedema secondary to RVO, or mCNV.

Conditions and MedDRA coding

Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), Myopic Choroidal Neovascularization (mCNV)

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Neovascular AMD, macular oedema secondary to RVO, or mCNV in the study eye
2. Study eye deemed to be indicated for ranibizumab IVT therapy at the discretion of the ophthalmologist (e.g., retina specialist)
3. Aged 18 years and older at the time of signing the informed consent form (ICF)
4. 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)
5. Willingness and ability to undertake all scheduled visits and assessments
6. 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.

Exclusion criteria 17

1. 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
2. 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
3. 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
4. History of excessive bleeding and recurrent haemorrhages, including any prior excessive intraocular bleeding or haemorrhages after IVT injection or intraocular procedures in either eye
5. History of massive subconjunctival haemorrhages of concern reported by the trial participant after an IVT injection in either eye
6. Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1
7. Treatment with any IVT injection within the 30 days prior to Day 1 in the study eye
8. 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
9. Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1
10. Treatment with any ocular IP in either eye within 90 days prior to Day 1
11. Treatment with systemic (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1
12. 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
13. 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
14. 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
15. Current systemic infectious disease or therapy for active infectious disease
16. Known history of intolerance, reaction to prior biological therapies
17. Pregnant or lactating women at Screening or at Day 1

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of successful task completions on all of 12 tasks (Day 1)

Secondary endpoints 3

1. Usability Endpoint • Percentage of successful completion on each of 12 tasks (Day 1)
2. Safety Endpoint • Incidence of adverse events (AEs) and serious adverse events (SAEs) from Day 1 to Day 7
3. Efficacy Endpoint • Change from baseline in BCVA at Day 7

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Samsung Bioepis Co. Ltd.

Sponsor organisation

Samsung Bioepis Co. Ltd.

Address

76 Songdogyoyuk Ro

City

Yeonsu

Postcode

21987

Country

Korea, Republic of

Scientific contact point

Organisation

Samsung Bioepis Co. Ltd.

Contact name

Information Desk

Public contact point

Organisation

Samsung Bioepis Co. Ltd.

Contact name

Information Desk

Third parties 3

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications