Trials / Completed
CompletedNCT03558074
Evaluate the Therapeutic Effects and Safety of ALK4290 in Patients With Refractory Wet Age-Related Macular Degeneration
A Single Arm Open-Label Study to Evaluate the Therapeutic Effects and Safety of a 6-Week Treatment Regimen of ALK4290 in Patients With Refractory Wet Age-Related Macular Degeneration (wAMD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Alkahest, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This study is designed to investigate the potential therapeutic effects and safety of oral ALK4290 administered 800 mg daily over a 6-week dosing period as measured by Best Corrected Visual Acuity (BCVA) in subjects with refractory wAMD (i.e., following monthly intravitreal \[IVT\] anti-VEGF therapy for at least 3 months in the study eye).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALK4290 | ALK4290 400 mg tablet twice a day |
Timeline
- Start date
- 2018-04-20
- Primary completion
- 2018-11-29
- Completion
- 2018-11-29
- First posted
- 2018-06-15
- Last updated
- 2020-12-22
- Results posted
- 2020-08-28
Locations
5 sites across 1 country: Hungary
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03558074. Inclusion in this directory is not an endorsement.