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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520599-24-00

Acronym

SB11-2002

Enrollment

Registered

2025-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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

Interventions

DRUGByooviz 10 mg/ml solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of successful task completions on all of 12 tasks (Day 1)	—

Secondary

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

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026