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

NCT06176963 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-12-30

Study results available
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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.

Conditions

  • Neovascular Age-related Macular Degeneration
  • Macular Edema
  • Retinal Vein Occlusion

Interventions

COMBINATION_PRODUCT

SB11 PFS

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

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Piotr Oleksy, M.D. · Centrum Medyczne Dietla 19 Krakow

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2023-11-30
Completion
2023-12-12
FDA Drug
Yes

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06176963 on ClinicalTrials.gov