Intravitreal Aflibercept in Wet Age Related Macular Degeneration Patients With an Incomplete Response to Routine Ranibizumab Injections

Sponsor
Unity Health Toronto
Study ID
NCT02002377
Phase
PHASE4
Status
Terminated

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Aflibercept — DRUG
    Aflibercept 2 mg (0.05 mL or 50 microliters) will be administered by intravitreal injection every 4 weeks for the first 8 weeks, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks for 36 weeks

Study Details

SHIFT-2 is a national, multi-center, non-randomized, open label trial of aflibercept in patients with wet age related macular degeneration who have incomplete response with routineranibizumab treatment.

Key Dates

Start date
Apr 17, 2014
Status verified
Apr 2018
Primary completion
Feb 21, 2017
Completion
Feb 21, 2017

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept
    Aflibercept 2 mg (0.05 mL or 50 microliters) will be administered by intravitreal injection every 4 weeks for the first 8 weeks, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks for 36 weeks

Primary Outcome Measure

'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT [ Time Frame: After 12 weeks of treatment ]

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