evaluate the therapeutic effects and safety of alk4290 in patients with refractory wet age-related macular degeneration

Conditions: Wet Age-related Macular Degeneration

Summary: this study will evaluate the therapeutic effects and safety of 800 mg alk4290 administered daily over a 6-week dosing period in subjects with refractory wet age-related macular degeneration (wamd).

this study is designed to investigate the potential therapeutic effects and safety of oral alk4290 administered 800 mg daily over a 6-week dosing period as measured by best corrected visual acuity (bcva) in subjects with refractory wamd (i.e., following monthly intravitreal \[ivt\] anti-vegf therapy for at least 3 months in the study eye).

Eligibility criteria:
inclusion criteria: * men and women with refractory active cnv secondary to amd, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye: * persistent exudation of srf and irf as documented by sd-oct and absence of improvement in visual acuity following monthly ivt anti-vegf therapy of at least 3 months; subject must have received their last ivt anti-vegf injection 30 to 90 days prior to the initial screening visit * central subfield retinal thickness ≥ 250 microns on sd-oct (exclusive of subretinal pigment epithelial fluid, inclusive of srf) * total lesion size not greater than 12 disc areas on fa * if present, subretinal hemorrhage must comprise \< 50% of the total lesion area on fa * no subfoveal fibrosis or atrophy on fa * bcva letter score, as measured by etdrs in the study eye, between 70 and 24 letters, inclusive, at screening * patients 50 years of age or older at screening visit 1 * body mass index (bmi) between18 and ≤ 40 at screening visit 1 * female subjects must not be pregnant or breastfeeding. women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in the study, she should inform her treating physician immediately * signed informed consent consistent with ich-gcp guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions exclusion criteria: * treatment with ivt anti-vegf therapy within 30 days preceding screening visit in the study eye and/or planned concomitant ivt anti-vegf treatment in the fellow eye during the study period * previous participation in any studies of investigational drugs within 1 month preceding screening visit * any form of macular degeneration that is not age-related (e.g., best's disease, stargardt's disease, sorsby's disease, etc.) * additional eye disease in the study eye that could compromise bcva (i.e., uncontrolled glaucoma (intraocular pressure \> 24) with visual field loss, clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, or genetic disorders such as retinitis pigmentosa; high myopia \> 8 diopters) * anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with fundus photography/fa or sd-oct * intraocular surgery in the study eye within 3 months prior to screening * aphakia or total absence of the posterior capsule (yttrium aluminum garnet (yag) laser capsulotomy permitted, a minimum of 1 month prior to enrollment) in the study eye

Keywords: refractory wamd