Evaluate the Therapeutic Effects and Safety of ALK4290 in Patients With Refractory Wet Age-Related Macular Degeneration
Condition: Wet Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: ALK4290
Intervention description: ALK4290 400 mg tablet twice a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Refractory wAMD

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).
    

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