Two-week Retreatment Interval Study for Treated Age-related Macular Degeneration Refractory to Monthly Aflibercept

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Tennessee Retina
Study ID
NCT03468296
Phase
PHASE4
Status
Unknown

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Intravitreal Aflibercept Injection 2mg — DRUG
    Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.

Study Details

This study is designed to evaluate the safety and efficacy of every 2 week intravitreal aflibercept injections in a population of neovascular AMD patients that have demonstrated refractory subretinal fluid with or without intraretinal fluid despite prior monthly intravitreal aflibercept treatment.

Key Dates

Start date
Apr 30, 2018
Status verified
Mar 2018
Primary completion
Oct 31, 2018
Completion
Jul 31, 2019

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Continued Q2 Week Treatment
    Will receive intravitreal aflibercept (2.0mg) injections for an additional four consecutive 2 week intervals at weeks 18, 20, 22, and 24
  • Active Comparator: Treat-And-Extend Treatment
    Will receive intravitreal aflibercept (2.0mg) injections on a treat-and-extend basis through week 24 with a minimum inter-treatment interval of q4 weeks.

Primary Outcome Measure

Adverse Events [ Time Frame: Through Week 14 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tennessee RetinaNashvilleTennessee37203
Eric Schneider, MD
[email protected]
615-983-6000
Carl Awh, MD (SUB_INVESTIGATOR)
Brandon Busbee, MD (SUB_INVESTIGATOR)
Kenneth Moffat, MD (SUB_INVESTIGATOR)
Peter Sonkin, MD (SUB_INVESTIGATOR)
Everton L Arrindell, MD (SUB_INVESTIGATOR)
Roy T Wallace, MD (SUB_INVESTIGATOR)
Eric Schneider, MD (PRINCIPAL_INVESTIGATOR)
David Reichstein, MD (SUB_INVESTIGATOR)
Franco Recchia, MD (SUB_INVESTIGATOR)

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