Phase 1b/2a Study of EYC-0305 in Patients With Neovascular Age-related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorEyconis INC.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
EYC-0305
Biological/VaccineExtended-delivery anti-VEGF
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: EYC-0305 Dose Level 1Experimental treatment 1 intervention
Group B: EYC-0305 Dose Level 2Experimental treatment 1 intervention
Group C: EYC-0305 Dose Level 3Experimental treatment 1 intervention
Group D: EYC-0305 Dose Level 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of ocular treatment-emergent adverse events (TEAEs)
Time frame
Week 722
Incidence and severity of systemic treatment-emergent adverse events (TEAEs)
Time frame
Week 72Sponsors and contacts
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Source ClinicalTrials.gov