A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD

NCT ID: NCT04331730

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2021-09-16

Brief Summary

This study will evaluate the efficacy and safety of AKST4290 in combination with aflibercept injections in subjects with newly diagnosed neovascular age-related macular degeneration (nAMD).

Detailed Description

This is a randomized, double-masked, placebo-controlled, dose-ranging, multicenter study to assess the efficacy and safety of AKST4290 administered orally at 400 mg b.i.d. or 800 mg b.i.d. in combination with intravitreal aflibercept injections (IAI), in subjects with newly diagnosed neovascular age-related macular degeneration (nAMD) who are naïve to treatment with anti-vascular endothelial growth factor (anti-VEGF) medications in the study eye. Subjects will be treated with AKST4290 800 mg daily, 1600 mg daily, or placebo for a total of 36 weeks.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AKST4290 (800 mg) + Aflibercept

Subjects will receive 400 mg AKST4290 twice daily for 36 weeks, in combination with intravitreal aflibercept injection treatment

Group Type: EXPERIMENTAL

AKST4290

Intervention Type: DRUG

Oral AKST4290

Aflibercept

Intervention Type: DRUG

Aflibercept intravitreal injection

AKST4290 (1600 mg) + Aflibercept

Subjects will receive 800 mg AKST4290 twice daily for 36 weeks, in combination with intravitreal aflibercept injection treatment

Group Type: EXPERIMENTAL

AKST4290

Intervention Type: DRUG

Oral AKST4290

Aflibercept

Intervention Type: DRUG

Aflibercept intravitreal injection

Placebo + Aflibercept

Subjects will receive placebo for 36 weeks, in combination with intravitreal aflibercept injection treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral placebo

Aflibercept

Intervention Type: DRUG

Aflibercept intravitreal injection

Interventions

AKST4290

Oral AKST4290

Intervention Type: DRUG

Placebo

Oral placebo

Intervention Type: DRUG

Aflibercept

Aflibercept intravitreal injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has been examined by a retinal specialist and found to be eligible to receive Intravitreal Aflibercept Injection (IAI) in the study eye.
• No prior treatment for Neovascular Age-Related Macular Degeneration (nAMD) in the study eye.
• Study eye has not undergone pars plana vitrectomy or glaucoma filtering surgery.
• Participation in studies of investigational drugs must have been discontinued within 30 days or 5 half-lives of the drug (whichever was longer) prior to screening.
• Central subfield thickness (CST) thickness ≥ 250 microns on SD-OCT (spectral domain OCT) (exclusive of subretinal pigment epithelial fluid, inclusive of SRF).
• Presence of SRF (subretinal fluid) and/or IRF (intraretinal fluid) on SD-OCT.
• Total lesion size not greater than 12 disc areas (30.48 mm2) (1 disc area = 2.54 mm2) on FA (fluorescein angiography).
• If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA, SD-OCT, or FP/FAF (fundus photography/fundus autofluorescence).
• No subfoveal fibrosis or atrophy on FA, SD-OCT, or FP/FAF.
• Active CNV (choroidal neovascularization) membranes with subfoveal leakage or juxtafoveal leakage too close for laser photocoagulation.
• BCVA (Best Corrected Visual Acuity) in the study eye between 70 and 24 letters inclusive.
• Body mass index (BMI) between (and inclusive of) 18 and 40 at screening.

Exclusion Criteria

• Participation in studies of investigational drugs within 30 days or 5 half-lives of the drug (whichever was longer) prior to screening.
• Known hypersensitivity to the active substance or any of the excipients of AKST4290 or aflibercept.
• Active or suspected ocular or periocular infection and/or active, severe intraocular inflammation.
• Any form of macular degeneration that is not age-related (e.g., Best's disease, Stargardt's disease, Sorsby's disease).
• Additional disease in the study eye that could compromise BCVA (i.e., uncontrolled glaucoma (IOP >24) with visual field loss, clinically significant diabetic macular edema, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, high myopia > 6 diopters, or genetic disorders such as retinitis pigmentosa).
• Presence of RPE (Retinal Pigment Epithelium) tears or rips in the study eye.
• Anterior segment and vitreous abnormalities in the study eye that would preclude adequate visualization with FP/FAF, 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 in an eye with a posterior chamber intraocular lens if performed a minimum of 1 month prior to enrollment) in the study eye.
• Known allergy to fluorescein sodium.
• Significant alcohol or drug abuse within past 2 years.
• Based on ECG (electrocardiogram) reading, subjects with a risk of QT prolongation.

• 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

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Retina Vitreous Associates of FL

St. Petersburg, Florida, United States

Sierra Eye Associates

Reno, Nevada, United States

Internationale Innovative Ophthalmochirurgie GbR

Düsseldorf, , Germany

nordBLICK Augenklinik Bellevue

Kiel, , Germany

Augentagesklinik Rheine

Rheine, , Germany

Jahn Ferenc Dél-pesti Kórház (Jahn Ferenc South-Pest Hospital)

Budapest, , Hungary

Magyar Honvédség Egészségügyi Központ, Szemészeti Osztály (Medical Centre, Hungarian Defence Forces, Ophthalmology Department)

Budapest, , Hungary

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház (Borsod-Abaúj-Zemplén County Hospital and University Teaching Hospital)

Miskolc, , Hungary

GANGLION Orvosi Központ

Pécs, , Hungary

Szegedi Tudományegyetem Általános Orvostudományi Kar, Szent-Györgyi Albert Klinikai Központ, Szemészeti Klinika, (University of Szeged Faculty of Medicine, Albert-Szent Gyorgyi Health Care, Department of Ophthalmology)

Szekszárd, , Hungary

Tęczówka (IRIS)

Bialystok, , Poland

Specjalistyczny Ośrodek Okulistyczny Oculomedica (Specialized Eye Center Oculomedica)

Bydgoszcz, , Poland

PROVISUS Sp. z o.o.

Częstochowa, , Poland

Optimum Profesorskie Centrum Okulistyki

Gdansk, , Poland

Centrum Medyczne Dietla 19 Sp zoo

Krakow, , Poland

Klinika Chirurgii Siatkówki i Ciała Szklistego Medical University in Lublin

Lublin, , Poland

Szpital św. Wojciecha

Poznan, , Poland

ArtOptica Salon Okulistyczno

Suwałki, , Poland

Centrum Medyczne UNO-MED

Tarnów, , Poland

Central Clinical Hospital of the MSWiA

Warsaw, , Poland

Countries

United States; Germany; Hungary; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AKST4290-205

Identifier Type: -

Identifier Source: org_study_id