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

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ClinicalTrials.gov Identifier: NCT02002377
Recruitment Status : Terminated (Inadequate enrollment due to investigational product becoming newly available on the Canadian market soon after study start)
First Posted : December 5, 2013
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: Aflibercept Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 17, 2014
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : February 21, 2017

Resource links provided by the National Library of Medicine


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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002377


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

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02002377     History of Changes
Other Study ID Numbers: 01
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Keywords provided by St. Michael's Hospital, Toronto:
Age Related Macular Degeneration, wet
aflibercept

Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents