evaluate the effects and safety of alk4290 in patients with newly diagnosed 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 newly diagnosed patients with wet age-related macular degeneration (wamd).

this study is designed to evaluate the therapeutic effects and safety of oral alk4290 administered at 800 mg daily over a 6-week dosing period in newly diagnosed (treatment naïve) patients with wamd. the study agent will be orally self-administered. all subjects will receive the study agent, alk4290. this study does not contain a placebo.

Eligibility criteria:
inclusion criteria: * men and women with newly diagnosed active cnv secondary to amd, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye: * no prior treatment for wamd in the study eye and no current or planned concomitant intravitreal anti-vegf treatment in the fellow eye * central subfield retinal thickness ≥ 250 microns on sd-oct (exclusive of subretinal pigment epithelial fluid, inclusive of srf) * presence of srf and/or irf on sd-oct * any active cnv with subfoveal leakage as determined by fa * 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. * 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: * 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) * the presence of polypoidal choroidal vasculopathy (pcv) or retinal angiomatous proliferation (rap) in the study eye * 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