A phase 2b multicenter dose-ranging study evaluating the safety and efficacy of a long-acting intravitreal sunitinib malate depot formulation (GB-102) compared to intravitreal aflibercept in subjects with neovascular (wet) age-related macular degeneration (ALTISSIMO Study)

HS 2019-5369
Eye, Macular Degeneration
Mitul Mehta, MD, MS
UCI Health Gavin Herbert Eye Institute, 850 Health Sciences Road, Irvine, CA 92697
To evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF).
  • You must be an adult age 50 and above.
  • You must be diagnosed with AMD within 12 weeks to 18 months prior to
    screening visit.
  • You must be treated with at least 3 IVT injections of an anti-VEGF agent.
If you choose to take part in this clinical trial and are eligible, your participation will last about 12 months.

If you are in the group that receives GB-102 and it proves to treat your condition more effectively,
you may benefit from participating in the study, but this cannot be guaranteed.

This study will help researchers learn more about GB-102, and it is hoped that this information
will help in the treatment of future patients with wet AMD.

None
Accepting Participants
Sunitinib
Adult
Rosie Magallon, senior clinical research coordinator, UCI Health Gavin Herbert Eye Institute
949-824-8297