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

Primary Purpose

Age Related Macular Degeneration

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Age Related Macular Degeneration, wet, aflibercept

Eligibility Criteria

51 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Calgary Retina Consultants
  • Alberta Retina Consultants
  • Capital District Health Authority
  • St. Joseph's Centre for Ambulatory Services
  • Hotel Dieu Hospital / Queen's
  • Ivey Eye Institute
  • St. Michael's Hospital
  • Toronto Western Hospital
  • Saskatoon Retina Consultants

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept

Arm Description

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

Outcomes

Primary Outcome Measures

'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT

Secondary Outcome Measures

'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
Change in central retinal thickness (CRT)
Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity

Full Information

First Posted
November 29, 2013
Last Updated
April 23, 2018
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02002377
Brief Title
Intravitreal Aflibercept in Wet Age Related Macular Degeneration Patients With an Incomplete Response to Routine Ranibizumab Injections
Acronym
SHIFT-2
Official Title
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
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment due to investigational product becoming newly available on the Canadian market soon after study start
Study Start Date
April 17, 2014 (Actual)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
February 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Age Related Macular Degeneration, wet, aflibercept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Intervention Description
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 Information:
Title
'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
Time Frame
16 weeks after treatment
Title
Change in central retinal thickness (CRT)
Time Frame
Weeks 12, 16, and 48
Title
Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity
Time Frame
Week 12, 16, and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Brent, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajeev Muni, MD, FRCSC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Calgary Retina Consultants
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0C8
Country
Canada
Facility Name
Alberta Retina Consultants
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 0X5
Country
Canada
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
St. Joseph's Centre for Ambulatory Services
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8G 5E4
Country
Canada
Facility Name
Hotel Dieu Hospital / Queen's
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Saskatoon Retina Consultants
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7S 0A7
Country
Canada

12. IPD Sharing Statement

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

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