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).
Who Can Participate?
Eligibility
Adults ages 50+ who:<ul>
<li>Are diagnosed with nAMD</li>
<li>Have not received any treatment for nAMD</li>
<li>Have not been treated for geographic atrophy</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu">DEC-RA@duke.edu.</a>
<li>Are diagnosed with nAMD</li>
<li>Have not received any treatment for nAMD</li>
<li>Have not been treated for geographic atrophy</li></ul>
For more information about who can be in this study, please contact the study team at <a href= "mailto: DEC-RA@duke.edu">DEC-RA@duke.edu.</a>
Age Range
55-89
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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:<ul>
<li>One group will get the OTX-TKI implant that contains the study drug</li>
<li>The other group will get another injection of aflibercept</li></ul>
This study will last about 2 years.
At various visits, you will have blood tests, answer questionnaires, and have eye exams and vision tests.
After the second screening visit, you will get a random assignment (like a coin flip) to 1 of 2 groups:<ul>
<li>One group will get the OTX-TKI implant that contains the study drug</li>
<li>The other group will get another injection of aflibercept</li></ul>
This study will last about 2 years.
At various visits, you will have blood tests, answer questionnaires, and have eye exams and vision tests.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular Degeneration. OTX-TKI-2023-AMD-301
Principal Investigator
Lejla
Vajzovic
Protocol Number
PRO00115279
NCT ID
NCT06223958
Phase
III
Enrollment Status
Pending Open to Enrollment