Trial | NCT03249740  Report issue

Title

A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
A Phase 1/2 Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of an Intravitreal Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular Age-related Macular Degeneration

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    32
The purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.
In this 2-part study, Part 1 is a multicenter, open-label, safety, tolerability, and systemic exposure evaluation to Sunitinib in escalating doses of a single IVT injection of GB-102, while Part 2 is a multicenter, double-masked, randomized (1:1:1), parallel-group, safety, and efficacy evaluation of repeated IVT injections of 2 dose levels of GB-102 compared with aflibercept.
Study Started
Aug 29
2017
Primary Completion
Sep 13
2018
Study Completion
Jan 16
2019
Last Update
Dec 20
2019

Drug GB-102

Intravitreal injection of GB-102

  • Other names: Sunitinib malate

Drug Aflibercept

Intravitreal injection of Aflibercept.

  • Other names: Anti-VEGF

Experimental: Phase 1 - GB-102 Experimental

Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102.

Experimental: Phase 2 - GB-102 Experimental

Low dose or high dose injected every 6 months

Active Comparator: Phase 2 - Aflibercept Active Comparator

Aflibercept 2 mg injected every 2 months

Criteria 

Key Inclusion Criteria:

Males or females of any race, ≥ 50 years of age
Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
Evidence of increased vascular permeability and/or loss of visual acuity

Key Exclusion Criteria:

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, IOP, hypothyroidism, or hyperthyroidism
Chronic renal disease
Abnormal liver function
Women who are pregnant or lactating
No Results Posted