Title

Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration
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)
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Study Participants

    30
This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in newly diagnosed patients with wet age-related macular degeneration (wAMD).
This study is designed to evaluate the therapeutic effects and safety of oral ALK4290 administered at 800 mg daily over a 6-week dosing period in newly diagnosed (treatment naïve) patients with wAMD. The study agent will be orally self-administered. All subjects will receive the study agent, ALK4290. This study does not contain a placebo.
Study Started
Apr 04
2018
Primary Completion
Nov 18
2018
Study Completion
Nov 18
2018
Results Posted
Aug 28
2020
Last Update
Dec 16
2020

Drug ALK4290

ALK4290 400 mg tablet twice a day

  • Other names: AKST4290, BI 144807

Active Experimental

ALK4290 800 mg daily

Criteria

Inclusion 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.
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:

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)
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

Summary

Active

All Events

Event Type Organ System Event Term Active

Best Corrected Visual Acuity (BCVA)

Mean change in BCVA letter score as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) method. The ETDRS chart assesses changes in vision based on the number of letters correctly read by the subject.

Active

7.0
letters (Mean)
Standard Deviation: 12.51

Incidence of Treatment-emergent Adverse Events (Safety)

Treatment-emergent adverse events identified by the Common Terminology Criteria for Adverse Events (CTCAE v4.03)

Active

Age, Continuous

73.1
years (Mean)
Standard Deviation: 8.78

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Active