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

  • STATUS
    Recruiting
  • day left to enroll
    1
  • participants needed
    100
  • sponsor
    Alkahest, Inc.
Updated on 29 July 2021
atrophy
aflibercept
aflibercept injection
glaucoma
spectral domain optical coherence tomography
fibrosis
photocoagulation
age-related macular degeneration
pars plana vitrectomy

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).

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 twice per day 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 nave 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.

Details
Condition Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age Related Macular Degeneration
Treatment Placebo, Aflibercept, AKST4290
Clinical Study IdentifierNCT04331730
SponsorAlkahest, Inc.
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

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, as assessed by a central reader
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 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
CST thickness 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
Presence of SRF and/or IRF on SD-OCT
Total lesion size not greater than 12 disc areas (30.48 mm2) (1 disc area = 2.54 mm2) on FA
If present, subretinal hemorrhage must comprise < 50% of the total lesion area on FA, SD-OCT, or FP/FAF
No subfoveal fibrosis or atrophy on FA, SD-OCT, or FP/FAF
Active CNV membranes with subfoveal leakage or juxtafoveal leakage too close for laser photocoagulation
BCVA 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 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 reading, subjects with a risk of QT prolongation
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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