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

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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.

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.

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
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Beverly Hills, California 90211
Phone: 310-289-2478
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Abilene, Texas 79606
Phone: 325-690-4414
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Arcadia, California 91007
Phone: 626-574-0188
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Arlington, Texas 76012
Phone: 682-433-5457
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Austin, Texas 78705
Phone: 512-279-1251
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Gilbert, Arizona
Phone: 602-222-2221
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Indianapolis, Indiana 46290
Phone: 317-805-4596
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Indianapolis, IN
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Lynbrook, New York 11563
Phone: 516-593-4026
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Miami, Florida
Phone: 305-643-8871
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San Antonio, Texas 78240
Phone: 210-697-2036
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