Neovascular (Wet) Age-Related Macular Degeneration
Conditions
Keywords
EYC-0305, TransCon aVEGF, wet AMD, neovascular AMD, treatment naive, Eyconis, anti-VEGF
Brief summary
This Phase 1b/2a study will primarily investigate the safety and tolerability of EYC-0305 delivered by intravitreal (IVT) injection every 24 weeks in patients with neovascular (wet) age-related macular degeneration (AMD). The pharmacokinetics (PK) and immunogenicity of EYC-0305, and the effect on disease activity and vision will also be evaluated.
Interventions
Extended-delivery anti-VEGF
Sponsors
Study design
Eligibility
Inclusion criteria
* Men or women 50 years and older with neovascular (wet) AMD meeting all study-specified eligibility criteria * Willing and able to comply with clinic visits and study-related procedures * Provide signed informed consent
Exclusion criteria
* Known hypersensitivity or known allergy that would preclude study drug administration * Inability to obtain ophthalmic imaging, eg, due to media opacity, inadequate pupillary dilation, allergy to fluorescein dye or lack of venous access * Uncontrolled diabetes mellitus * History of cerebrovascular accident (CVA) or myocardial infarction within 180 days of the Day 1 visit * Renal failure, dialysis, or history of renal transplant * Concurrent psychiatric or medical condition that in the opinion of the Investigator will interfere with study participation or completion * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of ocular treatment-emergent adverse events (TEAEs) | Week 72 |
| Incidence and severity of systemic treatment-emergent adverse events (TEAEs) | Week 72 |
Countries
United States