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

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

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

¿Quién puede participar en el Estudio?

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

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
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
Investigador Principal
Lejla Vajzovic, MD
Especialista en oftalmología
Número de Protocolo
IRB: PRO00117063
NCT: NCT06495918
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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