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

Phase 4

Terminated

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: Aflibercept

• Registration Number: NCT02002377
• Lead Sponsor: Unity Health 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-11-29
• Study First Posted: 2013-12-05
• Study Start: 2014-04-17
• Primary Completion: 2017-02-21
• Study Completion: 2017-02-21
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept	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

Name	Time	Method
'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT	After 12 weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Ivey Eye Institute; 🇨🇦 London, Ontario, Canada

St. Joseph's Centre for Ambulatory Services; 🇨🇦 Hamilton, Ontario, Canada

Hotel Dieu Hospital / Queen's; 🇨🇦 Kingston, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Capital District Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada

Calgary Retina Consultants; 🇨🇦 Calgary, Alberta, Canada

Saskatoon Retina Consultants; 🇨🇦 Saskatoon, Saskatchewan, Canada

Alberta Retina Consultants; 🇨🇦 Edmonton, Alberta, Canada