Summary

for people ages 50 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB‑102 compared with aflibercept.

Official Title

A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)

Details

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study 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)

Keywords

Neovascular Age-Related Macular Degeneration Age-related macular degeneration Choroidal neovascularization Macular Degeneration Sunitinib Drug: GB-102 Aflibercept GB-102 Dose 2 (1 mg) GB-102 Dose 3 (2 mg) Aflibercept 2 mg Dose

Eligibility

You can join if…

Open to people ages 50 years and up

  • Males or females ≥ 50 years of age
  • Presence of a CNV lesion secondary to AMD treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab).
  • Demonstrated response to prior anti-VEGF treatment since diagnosis
  • BCVA of 35 letters or better

You CAN'T join if...

  • History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
  • Uncontrolled hypertension, diabetes mellitus or IOP
  • Chronic renal disease
  • Abnormal liver function
  • Women who are pregnant or lactating

Locations

  • University of California Davis Eye Center accepting new patients
    Sacramento California 95817 United States
  • Bay Area Retina Associates accepting new patients
    Walnut Creek California 94598 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Graybug Vision
Links
Sign up for this study
ID
NCT03953079
Phase
Phase 2
Study Type
Interventional
Last Updated