Phase 1b/2a Study of EYC-0305 in Patients With Neovascular Age-related Macular Degeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EYC-0305.
- Who it may be relevant to
- Registry conditions: Neovascular (Wet) Age-Related Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Open-Label, Multiple Ascending Dose Phase 1b/2a Study of the Safety and Tolerability of Intravitreal (IVT) EYC-0305 in Patients With Neovascular Age-Related Macular Degeneration
Overview
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
- Biological EYC-0305
Extended-delivery anti-VEGF
Primary outcome measures
- Incidence and severity of ocular treatment-emergent adverse events (TEAEs) [Time frame: Week 72]
- Incidence and severity of systemic treatment-emergent adverse events (TEAEs) [Time frame: Week 72]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Beverly Hills, CA — Beverly Hills
- Wake Forest, NC — Wake Forest
- Erie, PA — Erie
- Bellaire, TX — Bellaire
- McAllen, TX — McAllen
- The Woodlands, TX — The Woodlands
Identifiers
NCT: NCT07587515 · EYC-0305-2501