Trials / Completed
CompletedNCT03558061
Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed 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 Newly Diagnosed Wet Age-Related Macular Degeneration (wAMD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (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 newly diagnosed patients with wet age-related macular degeneration (wAMD).
Detailed description
This study is designed to evaluate the therapeutic effects and safety of oral ALK4290 administered at 800 mg daily over a 6-week dosing period in newly diagnosed (treatment naïve) patients with wAMD. The study agent will be orally self-administered. All subjects will receive the study agent, ALK4290. This study does not contain a placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALK4290 | ALK4290 400 mg tablet twice a day |
Timeline
- Start date
- 2018-04-04
- Primary completion
- 2018-11-18
- Completion
- 2018-11-18
- First posted
- 2018-06-15
- Last updated
- 2020-12-16
- Results posted
- 2020-08-28
Locations
5 sites across 1 country: Hungary
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03558061. Inclusion in this directory is not an endorsement.