A Single Arm Open-Label Study to Evaluate the Therapeutic Effects and Safety of a 6-Week Treatment Regimen of ALK4290 in Patients with Refractory Wet Age-Related Macular Degeneration (wAMD)
- Conditions
- 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: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2017-004228-31-PL
- Lead Sponsor
- Alkahest, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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 monthly (between 4-6 weeks) IVT anti-VEGF therapy of at least 3 months, which must have occurred within the last 90 days prior screening.
•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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
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 (intra-ocular 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method