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

• Status: Completed
• Trial end date: 2021-09-16
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkahest, Inc.
• Treatments: Aflibercept

Criteria

Key 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.

Key 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.