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)

Active Clinical Trials // Jun 12 2019

Sponsor: Graybug Vision
Principal Investigator: Jonathan Chang, MD
Study Coordinator: Angie Adler 

Study Objective:

The purpose of this study is to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.

Study Design:

In this Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study, we will 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 treatment with anti-vascular endothelial growth factor (VEGF).

Diagnosis and Key Eligibility Criteria:

Patients aged 50 and older with a choroidal neovascular lesion (CNV) secondary to macular degeneration with at least 3 prior IVT injections that have demonstrated a response to this treatment. Vision must measure 20/200 or better.

Duration of Study: 13 months

 

For more information, contact Angie Adler 608-265-7557.