Trials / Completed
CompletedNCT04989699
Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
A Prospective Multicenter, Double-Masked, Randomized, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Ocular Therapeutix, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Detailed description
Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTX-TKI/Sham | OTX-TKI is one dose so subsequent visits will be sham to maintain the mask |
| DRUG | Aflibercept/Sham | Aflibercept administered every 8 weeks |
Timeline
- Start date
- 2021-07-28
- Primary completion
- 2023-02-06
- Completion
- 2023-12-18
- First posted
- 2021-08-04
- Last updated
- 2024-01-26
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04989699. Inclusion in this directory is not an endorsement.