The SOL-R Study (Age-Related Macular Degeneration) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Neovascular (Wet) Age-Related Macular Degeneration (nAMD)

Who Can Participate in the Study?

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.

Grupo etario
Adultos

What is Involved?

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.

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
Especialista en oftalmología
Protocol Number
IRB: PRO00117063
NCT: NCT06495918
Phase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción