Phase 2
N=107
A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD
Neovascular Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT04331730 ↗Enrolled (actual)
107
Serious AEs
5.6%
Results posted
Oct 2022
Primary outcome: Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ETDRS) Testing Method — 10.4; 6.7; 13.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AKST4290 (Drug); Placebo (Drug); Aflibercept (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Alkahest, Inc.
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ETDRS) Testing Method |
10.4; 6.7; 13.7 | — |
| SECONDARY Time to PRN Injection (Arms 1 and 2 Only) |
20.6; 20.1 | — |
| SECONDARY Median Number of Aflibercept Injections Received Beginning at Week 12 |
0.082; 0.083; 0.125 | — |
| SECONDARY Percentage of Subjects With Best Corrected Visual Acuity (BCVA) Change of ≥ 15 Letters |
30.6; 14.3; 41.7 | — |
| SECONDARY Mean Change in Central Subfield Thickness (CST) Compared With Control Through Week 12 |
-135.3; -162.7; -159.5 | — |
| SECONDARY Number of Participants With Adverse Events Assessed by Intensity |
15; 10; 11; 8; 7; 8 | — |
| SECONDARY Mean Change in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ETDRS) Testing Method as Compared With Control |
1.1; 2.3 | — |
| SECONDARY Time to the First Visit Where PRN Injection Criteria Are Met |
20.6; 20.1; 20.4 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT04331730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.