Overview

Evaluate the Therapeutic Effects and Safety of ALK4290 in Patients With Refractory Wet Age-Related Macular Degeneration

Status:
Completed
Trial end date:
2018-11-29
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alkahest, Inc.
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