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

Study Overview
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Brief Summary
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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.

Official Title
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The SHIFT-2 Study: Use of Intravitreal Aflibercept in Wet Age Related Macular Degeneration (AMD) Patients With an Incomplete Response to Routine Ranibizumab Injections

Conditions
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Age Related Macular Degeneration

Intervention / Treatment
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* Drug: Aflibercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Note: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study Age >50 years Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affect the fovea as evidenced by Fluorescein Angiography in the study eye Presence of intra or sub retinal fluid on SDOCT in the study eye Current treatment with uninterrupted routine (q35 +/- 7 days) ranibizumab started at least 3 months before Baseline (Week 0), having received at least 3 consecutive ranibizumab injections and no more than 24 injections maximum, with all ranibizumab injection intervals being 35 +/- 7 days apart ETDRS BCVA 20/30 and 20/320 (letter score of 78 to 25) in the study eye Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: Presence of purely serous pigment epithelial detachment in the study eye Any scarring or fibrosis involving the center of the fovea in the study eye Prior ocular or systemic treatment/surgery for wet AMD other than ranibizumab IVI monthly (in study the eye) Prior prn or treat and extend treatment with ranibizumab IVI between 3 to 24 months before Baseline (Week 0) in the study eye Prior treatment with systemic anti-VEGF therapy within the last 6 months in the study eye History of vitreous hemorrhage within the last 6 months in the study eye Prior vitrectomy in the study eye History of retinal detachment in the study eye History of macular hole of stage 2 and above in the study eye Presence of retinal pigment epithelial tears or rips involving the macula in the study eye. Any intraocular or periocular surgery/invasive procedure during the previous 6 months except lid surgery in the study eye Prior trabeculectomy or other filtration surgery in the study eye Uncontrolled glaucoma (≥ 25mmHg despite treatment with anti-glaucoma medications) in the study eye Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye. Scheduled for intraocular surgery during the study period in the study eye Concurrent retinal disease (i.e. diabetic retinopathy, retinal vein occlusion, retinal detachment, uveitis) in the study eye History of ocular or periocular infection/inflammation in the study eye within the last 4 weeks of screening Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aflibercept<br>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 | Drug: Aflibercept<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT |  | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT |  | 16 weeks after treatment | 
| Change in central retinal thickness (CRT) |  | Weeks 12, 16, and 48 | 
| Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity |  | Week 12, 16, and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age Related Macular Degeneration, wet, aflibercept