A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Graybug Vision
Study ID
NCT03249740
Phase
PHASE1
Status
Completed

Conditions

  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GB-102 — DRUG
    Intravitreal injection of GB-102
  • Aflibercept — DRUG
    Intravitreal injection of Aflibercept.

Study Details

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.

Key Dates

Start date
Aug 29, 2017
Status verified
Dec 2019
Primary completion
Sep 13, 2018
Completion
Jan 16, 2019

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: Experimental: Phase 2 - GB-102
    Low dose or high dose injected every 6 months
  • Active Comparator: Active Comparator: Phase 2 - Aflibercept
    Aflibercept 2 mg injected every 2 months

Primary Outcome Measure

Phase 1: Occurrence of ocular and nonocular adverse events (AEs) [ Time Frame: 8 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Retinal Consultants of ArizonaGilbertArizona85296-
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Midwest Eye InstituteIndianapolisIndiana46290-
Ophthalmic Consultants of Long IslandLynbrookNew York11563-
Retina Research Institute of TexasAbileneTexas79606-
Texas Retina AssociatesArlingtonTexas76012-
Retina Research Center, PLLCAustinTexas78705-
Medical Center Ophthalmology AssociatesSan AntonioTexas78240-

Find similar trials in Gilbert, AZ

By research site
Retinal Consultants of Arizona· Gilbert, AZRetina-Vitreous Associates Medical Group· Beverly Hills, CAMidwest Eye Institute· Indianapolis, INOphthalmic Consultants of Long Island· Lynbrook, NYRetina Research Institute of Texas· Abilene, TXTexas Retina Associates· Arlington, TX

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