EyeBiotech Ltd.
EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT. 40 participants will be enrolled in each cohort. Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion. All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. All participants will return at designated time points following each injection for safety and efficacy assessments. The Week 12 Visit will serve as the end of study visit for all participants.
EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT: * one cohort of 40 treatment naïve NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy), * one cohort of 40 incomplete responder (IR) NVAMD participants will be randomized (1:1) to 1…
Inclusion Criteria: Key General Inclusion Criteria • Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity Key Neovascular Age-related Macular Degeneration (NVAMD)-specific Inclusion Criteria * Be ≥ 50 years of age * Have treatment naive subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or juxtafoveal/extrafoveal CNV with foveal involvement * For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days pr…
EYE103 is a humanized antibody formulated for intravitreal administration
Aflibercept 2.0 mg is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with Neovascular Age-Related Macular Degeneration (NVAMD). Aflibercept 2.0 mg is only administered to 2 cohorts of Incomplete Responders (IR) with NVAMD in combination with Low Dose or High Dose EYE103.