Phase 2
N=30
Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration
Wet Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT03558061 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Best Corrected Visual Acuity (BCVA) — 7.0 letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ALK4290 (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Alkahest, Inc.
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Corrected Visual Acuity (BCVA) |
7.0 | — |
| SECONDARY Incidence of Treatment-emergent Adverse Events (Safety) |
14 | — |
Summary
This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in newly diagnosed patients with wet age-related macular degeneration (wAMD).
Eligibility Criteria
Inclusion Criteria
- Men and women with newly diagnosed active CNV secondary to AMD, diagnosed by a retinal specialist with all the following characteristics and ophthalmic inclusion criteria applied to the study eye:
- No prior treatment for wAMD in the study eye and no current or planned concomitant intravitreal anti-VEGF treatment in the fellow eye
- Central subfield retinal thickness ≥ 250 microns on SD-OCT (exclusive of subretinal pigment epithelial fluid, inclusive of SRF)
- Presence of SRF and/or IRF on SD-OCT
- Any active CNV with subfoveal leakage as determined by FA
- 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)
- The presence of polypoidal choroidal vasculopathy (PCV) or retinal angiomatous proliferation (RAP) in the study eye
- 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 (NCT03558061). 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.