A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: AKST4290; Placebo; Aflibercept
Intervention description: Oral AKST4290; Oral placebo; Aflibercept intravitreal injection
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

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).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men and women with newly diagnosed active Choroidal Neovascularization (CNV) secondary
             to Age-Related Macular Degeneration (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 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.

        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 (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.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.