Age Related Macular Degeneration
Conditions
Keywords
Age Related Macular Degeneration, wet, aflibercept
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.
Interventions
DRUGAflibercept
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
Sponsors
Unity Health Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
51 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT | After 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT | 16 weeks after treatment |
| Change in central retinal thickness (CRT) | Weeks 12, 16, and 48 |
| Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity | Week 12, 16, and 48 |
Countries
Canada
Outcome results
None listed