Loading clinical trials...

A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Double-Masked, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy of Oral AKST4290 With Loading Doses of Aflibercept in Patients With Newly Diagnosed Neovascular Age-Related Macular Degeneration

NCT04331730•Alkahest, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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.
+2 more criteria

Locations (21)

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

Key Dates

Start Date

January 28, 2020

Primary Completion Date

August 19, 2021

Completion Date

September 16, 2021

Last Updated

October 26, 2022

Enrollment

107

ACTUAL participants

Conditions

Neovascular Age-related Macular Degeneration

Interventions

AKST4290

DRUG

Placebo

DRUG

Aflibercept

DRUG

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

NCT05562947

Neovascular Age-related Macular DegenerationnAMD

View study

RECRUITINGPHASE3

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

NCT05904028

Neovascular Age-related Macular Degeneration

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Gene Therapy(FT-003) for Wet AMD

Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products