A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Graybug Vision
Study ID
NCT03953079
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular Age-Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Drug: GB-102 — DRUG
    Intravitreal injection of GB-102
  • Aflibercept — DRUG
    Intravitreal injection of aflibercept (2 mg dose)

Study Details

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.

Key Dates

Start date
Sep 26, 2019
Status verified
Jan 2022
Primary completion
Dec 15, 2020
Completion
Jun 3, 2021

Study Design

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

Arms

  • Experimental: GB-102 1 mg/1 mg
    Participants will receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
  • Experimental: GB-102 2 mg/1 mg
    Participants will receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.
  • Active Comparator: Aflibercept 2 mg
    Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Primary Outcome Measure

Time to First Rescue Treatment [ Time Frame: Baseline through 12 months ]

Locations (33)

FacilityCityStateZIPSite coordinators
Retinal Consultants AZGilbertArizona85296-
Retinal Research InstitutePhoenixArizona85017-
California Retina Research ConsultantsBakersfieldCalifornia93309-
Retinal Diagnostic Center of Northern CaliforniaCampbellCalifornia95008-
The Retina PartnersEncinoCalifornia91436-
Retina Consultants of Orange CountyFullertonCalifornia92835-
Northern California Retina Vitreous Associates Medical Group, Inc.Mountain ViewCalifornia94040-
West Coast Retina Medical Group, Inc.San FranciscoCalifornia94109-
California Retina Consultants - CRCSanta BarbaraCalifornia93103-
Bay Area Retina AssociatesWalnut CreekCalifornia94598-
Specialty Retina CenterCoral SpringsFlorida32503-
Florida Retina InstituteOrlandoFlorida32806-1101-
Retina Specialty InstitutePensacolaFlorida32503-
Eye Associates of PinellasPinellas ParkFlorida33782-
Southeast Retina CenterAugustaGeorgia30909-
Retina Consultants of Hawaii‘AieaHawaii96701-
University Retina and MaculaLemontIllinois60439-
Wolfe Eye Clinic - West Des MoinesDes MoinesIowa50266-
Eye Associates of Northeast LouisianaWest MonroeLouisiana71291-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Mid Atlantic Retina SpecialistsHagerstownMaryland21740-
Sierra Eye AssociatesRenoNevada89502-
Ophthalmic Consultants of Long IslandOceansideNew York11572-
Sterling ResearchCincinnatiOhio45219-
Black Hills Regional Eye InstituteRapid CitySouth Dakota57701-
Retina Research Institute of TexasAbileneTexas79606-
Austin Retina AssociatesAustinTexas78705-
Retina Research Center, PLLCAustinTexas78705-
Retina SpecialistsPlanoTexas75093-
Retina Consultants of HoustonThe WoodlandsTexas77384-
Strategic Clinical Research Group LLCWillow ParkTexas76087-
Piedmont Eye CenterLynchburgVirginia24502-
Retina Center NW PLLCSilverdaleWashington98383-

Find similar trials in Gilbert, AZ

By research site
Retinal Consultants AZ· Gilbert, AZRetinal Research Institute· Phoenix, AZCalifornia Retina Research Consultants· Bakersfield, CARetinal Diagnostic Center of Northern California· Campbell, CAThe Retina Partners· Encino, CARetina Consultants of Orange County· Fullerton, CA

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