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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 21, 2017

Interventions

  • Drug: 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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • ‘OCT defined success’ defined by no presence of intra or sub retinal fluid on SDOCT
    • Time Frame: After 12 weeks of treatment

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

Note: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study

1. Age >50 years

2. 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

3. Presence of intra or sub retinal fluid on SDOCT in the study eye

4. 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

5. 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:

1. Presence of purely serous pigment epithelial detachment in the study eye

2. Any scarring or fibrosis involving the center of the fovea in the study eye

3. Prior ocular or systemic treatment/surgery for wet AMD other than ranibizumab IVI monthly (in study the eye)

4. Prior prn or treat and extend treatment with ranibizumab IVI between 3 to 24 months before Baseline (Week 0) in the study eye

5. Prior treatment with systemic anti-VEGF therapy within the last 6 months in the study eye

6. History of vitreous hemorrhage within the last 6 months in the study eye

7. Prior vitrectomy in the study eye

8. History of retinal detachment in the study eye

9. History of macular hole of stage 2 and above in the study eye

10. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.

11. Any intraocular or periocular surgery/invasive procedure during the previous 6 months except lid surgery in the study eye

12. Prior trabeculectomy or other filtration surgery in the study eye

13. Uncontrolled glaucoma (≥ 25mmHg despite treatment with anti-glaucoma medications) in the study eye

14. 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.

15. Scheduled for intraocular surgery during the study period in the study eye

16. Concurrent retinal disease (i.e. diabetic retinopathy, retinal vein occlusion, retinal detachment, uveitis) in the study eye

17. History of ocular or periocular infection/inflammation in the study eye within the last 4 weeks of screening

18. Pregnant or breastfeeding

Gender Eligibility: All

Minimum Age: 51 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Michael’s Hospital, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael H Brent, MD, FRCSC, Principal Investigator, St. Michael’s Hospital, Toronto
    • Rajeev Muni, MD, FRCSC, Principal Investigator, St. Michael’s Hospital, Toronto

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