SOL-R-OTX-TKI-2023-AMD-303 (Age-Related Macular Degeneration)

Purpose of this Study

We are doing this study to find out if an investigational implanted drug called Ocular Therapeutix Tyrosine Kinase Inhibitor Axitinib (the study drug) is a safe and effective option for people with nAMD.

Who Can Participate?

Eligibility

Adults ages 50+ who:
  • Are diagnosed with nAMD
  • Have never had eye surgery and do not have any current plans for eye surgery
For more information, contact the study team at DEC_ResearchAdmin@duke.edu.

Age Range

50-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (by chance) to 1 of 3 groups:
  • Group 1: You will get the study drug implanted
  • Group 2: You will get 2 mg aflibercept injections (standard drug)
  • Group 3: You will get 8 mg aflibercept injections
The study drug implant is made with a gel-like structure that is designed to dissolve in the eye and be resorbed by the body and does not need to be removed. Participation in the study will last approximately 16.5 months (72 weeks) for each participant. Duration includes up to 24 weeks of screening, 40 weeks of drug regimen, and 8 weeks of follow-up.

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-303 - SOL-R

Principal Investigator

Lejla
Vajzovic

Protocol Number

PRO00117063

NCT ID

NCT06495918

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov