Trials / Completed
CompletedNCT03633084
RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration
Phase 1/2 Open Label, Dose-escalation Study of the Safety and OcUlar Tolerability of a Single Intravitreal Injection of RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration (SUSHI)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Ribomic USA Inc · Industry
- Sex
- All
- Age
- 55 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label, non-controlled, dose-escalating study assessing the safety, tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in approximately nine subjects with exudative age-related macular degeneration.
Detailed description
Nine subjects in three dose cohorts (3 subjects each cohort) will receive a single i.vt. injection of RBM-007 in the study eye. Subjects will be followed through Day 56.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RBM-007 Injectable Solution | (No additional description) |
Timeline
- Start date
- 2018-08-29
- Primary completion
- 2019-06-26
- Completion
- 2019-06-26
- First posted
- 2018-08-16
- Last updated
- 2021-01-05
- Results posted
- 2021-01-05
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03633084. Inclusion in this directory is not an endorsement.