Refractory Wet Age-Related Macular Degeneration (wAMD) MedDRA version: 20.0 Level: LLT Classification code 10075568 Term: Wet age-related macular degeneration System Organ Class: 100000004853
Conditions
Sponsors
Alkahest, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible for inclusion, all subjects must meet the following 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 3 consecutive (approximately 4 to 6 weeks apart) IVT anti-VEGF injections; 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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion if any of the following criteria apply: • Treatment with IVT anti-VEGF therapy within 30 days preceding screening visit (Visit 1) 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 (Visit 1) • 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 • Known allergy to fluorescein sodium for injection in FA • Current or planned use of medications known to be toxic to the retina, lens, or optic nerve (e.g.desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol) • Medical history or condition: - Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) > 8% - Myocardial infarction or stroke within 12 months of screening - Active bleeding disorder - Concomitant use of warfarin or anticoagulation therapy - Major surgery within 1 month of screening or planned within the study period - Hepatic impairment - Uncontrolled hypertension - Positive screening for Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) • Planned concomitant use of cytochrome P450 3A4 (CYP3A4) or P-glycoprotein (P-gp) inhibitors or inducers during the study • Planned concomitant use of P-gp substrates that are narrow therapeutic index drugs (e.g., digoxin) • Use of systemic steroids (>10 mg prednisone or equivalent/day) within 14 days of first dose of study agent or known diseases which could require the use of systemic steroids within the study period • Use of intravitreal steroids: - Dexamethasone (Ozurdex) or triamcinolone within 6 months prior to screening - Flucinolon (Retisert or Iluvien) within 48 months prior to screening • Patients with a clinically relevant abnormal screening hematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in other exclusion criteria (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.0-fold the upper limit of normal at screening; total bilirubin or prothrombin time (INR) > 1.5 times the upper limit of normal at screening). Laboratory testing may be repeated once during the screening phase. • Patients with impaired renal function defined as calculated glomerular filtration rate (GFR) < 30 mL/min • Significant alcohol or drug abuse within past 2 years • Based
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the potential therapeutic effects of a 6-week, twice daily oral dosing regimen of ALK4290 on BCVA, as measured by ETDRS, in subjects with refractory wAMD following treatment with IVT anti-VEGF. ;Secondary Objective: As a secondary objective, the study will assess the safety of the proposed dosing regimen. ;Primary end point(s): The primary endpoint is mean changes in BCVA as measured by the ETDRS testing method. ;Timepoint(s) of evaluation of this end point: 10 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is safety as assessed by incidence, seriousness, and severity of adverse events.;Timepoint(s) of evaluation of this end point: 10 week | — |
Countries
Hungary, Poland
Contacts
Public ContactJonas Hannestad
Alkahest, Inc.
Outcome results
None listed