Phase 2
Completed N=26
Evaluate the Therapeutic Effects and Safety of ALK4290 in Patients With Refractory Wet Age-Related Macular Degeneration
Wet Age-related Macular Degeneration
Source: ClinicalTrials.gov NCT03558074 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Best Corrected Visual Acuity (BCVA) — 2.0 letters
Summary
This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in subjects with refractory wet age-related macular degeneration (wAMD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Corrected Visual Acuity (BCVA) |
2.0 | — |
| SECONDARY Incidence of Treatment-emergent Adverse Events (Safety) |
8 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women with refractory active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:
- Persistent exudation of SRF and IRF as documented by SD-OCT and absence of improvement in visual acuity following monthly IVT anti-VEGF therapy of at least 3 months; subject must have received their last IVT anti-VEGF injection 30 to 90 days prior to the initial screening visit
- Central subfield retinal thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
- Total lesion size not greater than 12 disc areas on FA
- If present, subretinal hemorrhage must comprise 24) with visual field loss, clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, vitreomacular traction, monocular vision, or genetic disorders such as retinitis pigmentosa; high myopia > 8 diopters)
- Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with fundus photography/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, a minimum of 1 month prior to enrollment) in the study eye
Data sourced from ClinicalTrials.gov (NCT03558074). 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. Informational only — not medical advice.