OTX-TKI-2023-AMD-301 (Neovascular Age-Related Macular Degeneration) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called axitinib (the study drug) is a safe and effective option for people with neovascular age-related macular degeneration (nAMD). The study drug is given to people using a developing technology called the Ocular Therapeutix Intravitreal Implant (OTX-TKI).
Neovascular Age-Related Macular Degeneration (nAMD) AKA "Wet AMD"
Who Can Participate in the Study?
Adults ages 50+ who:
- Are diagnosed with nAMD
- Have not received any treatment for nAMD
- Have not been treated for geographic atrophy
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
What is Involved?
If you choose to join this study, you will come to our clinic at the Duke Eye Center for 2 screening visits to get a drug called aflibercept, which is an FDA-approved treatment for nAMD. You will get a 2mg injection of this drug at the first screening visit, and you will get a 1mg injection at the second screening visit 4 weeks later.
After the second screening visit, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- One group will get the OTX-TKI implant that contains the study drug
- The other group will get another injection of aflibercept
This study will last about 2 years.
At various visits, you will have blood tests, answer questionnaires, and have eye exams and vision tests.
Study Details
