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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
107
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ETDRS) Testing Method
Mean change from baseline in Best Corrected Visual Acuity (BCVA) per the Early Treatment Diabetic Retinopathy Study (ETDRS) testing method. BCVA will be assessed using ETDRS charts at 4 meters initial testing distance and assessed in both eyes. Score range is 0 to 93. A higher score indicates better vision.
Time frame: Baseline to Week 36
Time to PRN Injection (Arms 1 and 2 Only)
Time to first use of intravitreal aflibercept injection, as needed (AKST4290 Arms only). UNITS: weeks.
Time frame: Baseline to Week 36
Median Number of Aflibercept Injections Received Beginning at Week 12
Median number of injections received beginning at Week 12 as a rate. UNITS: number of injections per week from Week 12
Time frame: Week 12 to Week 36
Percentage of Subjects With Best Corrected Visual Acuity (BCVA) Change of ≥ 15 Letters
Percentage of subjects with Best Corrected Visual Acuity (BCVA) change of ≥ 15 letters at Week 36.
Time frame: Baseline to Week 36
Mean Change in Central Subfield Thickness (CST) Compared With Control Through Week 12
Mean change in Central Subfield Thickness (CST) compared with control through Week 12. UNITS: micrometre
Time frame: Baseline to Week 12
Number of Participants With Adverse Events Assessed by Intensity
Number of Participants with Adverse Events categorized by intensity
Time frame: Screening to Week 40
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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
...and 11 more locations
Mean Change in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ETDRS) Testing Method as Compared With Control
Mean change in Best Corrected Visual Acuity (BCVA) letter score per the Early Treatment Diabetic Retinopathy Study (ETDRS) testing method from Week 12 as compared to control at Week 36. BCVA will be assessed using ETDRS charts at 4 meters initial testing distance and assessed in both eyes. Score range is 0 to 93. A higher score indicates better vision.
Time frame: Week 12 to Week 36
Time to the First Visit Where PRN Injection Criteria Are Met
Time to the first visit where PRN injection criteria are met starting at Week 12 will be calculated in weeks as the first date where PRN injection criteria are first met minus the date of first dose of study drug plus one, divided by seven. Subjects who do not experience the event of interest (meet the criteria for PRN IAI) while on the study will be censored at their last visit completed through Week 36. Units: weeks
Time frame: Week 12 to the first visit meeting PRN injection criteria through week 36