Trials / Completed
CompletedNCT02555306
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Santen Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 0.5 mg of DE-122 | DE-122 Injectable Solution |
| DRUG | 1.0 mg of DE-122 | DE-122 Injectable Solution |
| DRUG | 2.0 mg of DE-122 | DE-122 Injectable Solution |
| DRUG | 4.0 mg of DE-122 | DE-122 Injectable Solution |
Timeline
- Start date
- 2015-09-16
- Primary completion
- 2017-08-01
- Completion
- 2017-08-01
- First posted
- 2015-09-21
- Last updated
- 2020-01-14
- Results posted
- 2020-01-14
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02555306. Inclusion in this directory is not an endorsement.