A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV

NCT07550504 | Completed Phase 2

• 2 other identifiers: SB11-20022025-520599-24-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 trial participants with nAMD, Macular Oedema Secondary to RVO, or Myopic Choroidal Neovascularization (mCNV).

Conditions

Myopic Choroidal Neovascularization; Age-Related Macular Degeneration; Branch Retinal Vein Occlusion With Macular Edema; Central Retinal Vein Occlusion With Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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)

  From Day 1 to Day 7

Study Arms (1)

SB11 PFS

EXPERIMENTAL

Trial participants received a single dose of SB11 PFS containing 0.5 mg ranibizumab in 0.05 mL solution.

Combination Product: SB11 PFS

Interventions

SB11 PFS COMBINATION_PRODUCT

SB11 provided in a pre-filled syringe (PFS) containing 0.5 mg ranibizumab in 0.05 mL for intravitreal injection

Also known as: ranibizumab

SB11 PFS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Treatment with any IVT injection within the 30 days prior to Day 1 in the study eye
• Uncontrolled intraocular pressure (IOP) greater than (≥) 25 mmHg in the study eye at Screening or at Day 1
• Treatment with systemic (non-ocular) anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days prior to Day 1
• Ocular laser surgery in study eye at any time within the past 30 days prior to Day 1

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (2)

Research site

Krakow, Poland

Location

Research site

Olsztyn, Poland

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: March 30, 2026
• Primary Completion: March 31, 2026
• Study Completion: April 9, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

PL (2)