Trials / Completed
CompletedNCT03479372
Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
A Randomized, Double Masked, Uncontrolled , Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants With Neovascular Age-Related Macular Degeneration (AMD)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- PanOptica, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.
Detailed description
Patients with newly diagnosed, active, pathologic CNV associated with neovascular AMD will be screened for inclusion into the study after providing written informed consent. Participants who are eligible for the study will be centrally randomized at Day 1 to one of three doses of PAN-90806 Eye Drops. Participants will be instructed to apply one drop of PAN-90806 to the ocular surface of the identified study eye once daily for twelve (12) weeks. Participants will return for follow-up visits at Week 2, Week 4, Week 8, Week 12, 1 week after stopping PAN-90806 treatment and 1 month after stopping PAN-90806 treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PAN-90806 Ophthalmic Suspension | PAN-90806 provided in single-use dropper bottles for topical ocular administration |
Timeline
- Start date
- 2018-04-26
- Primary completion
- 2019-05-27
- Completion
- 2019-06-27
- First posted
- 2018-03-27
- Last updated
- 2019-07-09
Locations
18 sites across 5 countries: United States, Czechia, Hungary, Latvia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03479372. Inclusion in this directory is not an endorsement.