Intravitreal Aflibercept in Wet Age Related Macular Degeneration Patients With an Incomplete Response to Routine Ranibizumab Injections (SHIFT-2)

April 23, 2018 updated by: Unity Health Toronto

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 0C8
        • Calgary Retina Consultants
      • Edmonton, Alberta, Canada, T5H 0X5
        • Alberta Retina Consultants
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Capital District Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8G 5E4
        • St. Joseph's Centre for Ambulatory Services
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital / Queen's
      • London, Ontario, Canada, N6A 4V2
        • Ivey Eye Institute
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M5B1W8
        • St. Michael's Hospital
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7S 0A7
        • Saskatoon Retina Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Michael H Brent, MD, FRCSC, Unity Health Toronto
  • Principal Investigator: Rajeev Muni, MD, FRCSC, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2014

Primary Completion (Actual)

February 21, 2017

Study Completion (Actual)

February 21, 2017

Study Registration Dates

First Submitted

November 29, 2013

First Submitted That Met QC Criteria

November 29, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age Related Macular Degeneration

Clinical Trials on Aflibercept

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe