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

NCT03558061 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ALK4290-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 weeks

Secondary Outcomes (1)

• Incidence of Treatment-emergent Adverse Events (Safety)

  Baseline to 10 weeks

Study Arms (1)

Active

EXPERIMENTAL

ALK4290 800 mg daily

Drug: ALK4290

Interventions

ALK4290 DRUG

ALK4290 400 mg tablet twice a day

Also known as: AKST4290, BI 144807

Active

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkahest, Inc.: lead

Study Sites (5)

Jahn Ferenc South-Pest Hospital and Clinic

Budapest, Hungary

Location

Borsod-Abauj-Zemplen County Hospital and Teaching Hospital

Miskolc, Hungary

Location

Szabolcs-Szatmar-Bereg County Hospital and University Hospital

Nyíregyháza, Hungary

Location

University of Szeged Faculty of Medicine

Szeged, Hungary

Location

Markusovszky University Teaching Hospital

Szombathely, Hungary

Location

Results Point of Contact

• Title: Head of Communications
• Organization: Alkahest, Inc.

info@alkahest.com

(650) 801-0474

Study Officials

• Alkahest Medical Monitor

  Alkahest, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 15, 2018
• Study Start: April 4, 2018
• Primary Completion: November 18, 2018
• Study Completion: November 18, 2018
• Last Updated: December 16, 2020
• Results First Posted: August 28, 2020

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (5)