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

NCT ID: NCT03558074

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2018-11-29

Brief 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).

Detailed Description

This study is designed to investigate the potential therapeutic effects and safety of oral ALK4290 administered 800 mg daily over a 6-week dosing period as measured by Best Corrected Visual Acuity (BCVA) in subjects with refractory wAMD (i.e., following monthly intravitreal [IVT] anti-VEGF therapy for at least 3 months in the study eye).

Conditions

Wet Age-related Macular Degeneration

Keywords

Refractory wAMD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

ALK4290 800 mg daily

Group Type: EXPERIMENTAL

ALK4290

Intervention Type: DRUG

ALK4290 400 mg tablet twice a day

Interventions

ALK4290

ALK4290 400 mg tablet twice a day

Intervention Type: DRUG

Other Intervention Names

AKST4290; BI 144807

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alkahest, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alkahest Medical Monitor

Role: STUDY_DIRECTOR

Alkahest, Inc.

Locations

Jahn Ferenc South-Pest Hospital and Clinic

Budapest, , Hungary

Borsod-Abauj-Zemplen County Hospital and Teaching Hospital

Miskolc, , Hungary

Szabolcs-Szatmar-Bereg County Hospital and University Hospital

Nyíregyháza, , Hungary

University of Szeged Faculty of Medicine

Szeged, , Hungary

Markusovszky University Teaching Hospital

Szombathely, , Hungary

Countries

Hungary

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ALK4290-202

Identifier Type: -

Identifier Source: org_study_id