A Single Arm Open-Label Study to Evaluate the Therapeutic Effects and Safety of a 6-Week Treatment Regimen of ALK4290 in Patients with Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD).
- Conditions
- ewly Diagnosed Wet Age-Related Macular Degeneration (wAMD)MedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2017-004227-75-HU
- Lead Sponsor
- Alkahest, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
In order to be eligible for inclusion, all subjects must meet the following 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. 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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
A subject will not be eligible for inclusion if any of the following criteria apply:
• Previous participation in any studies of investigational drugs within 1 month preceding screening visit (Visit1)
• 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
• 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 (TB) 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 ab
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