Clinical trial NCT02002377: Intravitreal Aflibercept in Wet Age Related Macular Degeneration Patients With an Incomplete Response to Routine Ranibizumab Injections
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Age Related Macular Degeneration
Keywords: Age Related Macular Degeneration, wet
aflibercept
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 23
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
timeFrame: 16 weeks after treatment
measure: Change in central retinal thickness (CRT)
timeFrame: Weeks 12, 16, and 48
measure: Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity
timeFrame: Week 12, 16, and 48
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Retina Consultants
state: Alberta
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Centre for Ambulatory Services
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital / Queen's
state: Ontario
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Retina Consultants
state: Saskatchewan
Study officials:
affiliation: Unity Health Toronto
name: Michael H Brent, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Rajeev Muni, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: