Status:
COMPLETED
A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD
Lead Sponsor:
Alkahest, Inc.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 combinat...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
January 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2021
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04331730
Start Date
January 28 2020
End Date
September 16 2021
Last Update
October 26 2022
Active Locations (21)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Retina Vitreous Associates of FL
St. Petersburg, Florida, United States, 33711
3
Sierra Eye Associates
Reno, Nevada, United States, 89502
4
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf, Germany