A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
NCT ID: NCT03249740
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2017-08-29
2019-01-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental: Phase 1 - GB-102
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.
GB-102
Intravitreal injection of GB-102
Experimental: Phase 2 - GB-102
Low dose or high dose injected every 6 months
GB-102
Intravitreal injection of GB-102
Active Comparator: Phase 2 - Aflibercept
Aflibercept 2 mg injected every 2 months
Aflibercept
Intravitreal injection of Aflibercept.
Interventions
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GB-102
Intravitreal injection of GB-102
Aflibercept
Intravitreal injection of Aflibercept.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism
3. Chronic renal disease
4. Abnormal liver function
5. Women who are pregnant or lactating
50 Years
ALL
No
Sponsors
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Graybug Vision
INDUSTRY
Responsible Party
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Principal Investigators
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Charles P. Semba, MD
Role: STUDY_DIRECTOR
Graybug Vision, Inc.
Locations
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Retinal Consultants of Arizona
Gilbert, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Retina Research Center, PLLC
Austin, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Countries
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Other Identifiers
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GBV-102-001
Identifier Type: -
Identifier Source: org_study_id
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