A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 6/30/2018 |
Start Date: | August 29, 2017 |
End Date: | March 2020 |
Contact: | VP, Global Clinical Development Operations |
Email: | vsmith@graybug.com |
Phone: | (650) 487-2800 |
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
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.
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.
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.
Key Inclusion Criteria:
1. Males or females of any race, ≥ 50 years of age
2. 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)
3. Evidence of increased vascular permeability and/or loss of visual acuity
Key Exclusion Criteria:
1. 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
2. Uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism
3. Chronic renal disease
4. Abnormal liver function
5. Women who are pregnant or lactating
We found this trial at
10
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials