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

Age Related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02002377
• Other study ID #: 01
• Status: Terminated
• Phase: Phase 4
• First received: November 29, 2013
• Last updated: April 23, 2018
• Start date: April 17, 2014
• Est. completion date: February 21, 2017

Study information

• Verified date: April 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: February 21, 2017
• Est. primary completion date: February 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Canada	Calgary Retina Consultants	Calgary	Alberta
Canada	Alberta Retina Consultants	Edmonton	Alberta
Canada	Capital District Health Authority	Halifax	Nova Scotia
Canada	St. Joseph's Centre for Ambulatory Services	Hamilton	Ontario
Canada	Hotel Dieu Hospital / Queen's	Kingston	Ontario
Canada	Ivey Eye Institute	London	Ontario
Canada	Saskatoon Retina Consultants	Saskatoon	Saskatchewan
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT		After 12 weeks of treatment
Secondary	'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT		16 weeks after treatment
Secondary	Change in central retinal thickness (CRT)		Weeks 12, 16, and 48
Secondary	Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity		Week 12, 16, and 48