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

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02002377
• Collaborator: (none)
• Enrollment: 23
• Locations: 9
• Arm: 1
• Actual Duration (Months): 34.2
• Patients Per Site: 2.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• 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: Apr 17, 2014
• Actual Primary Completion Date: Feb 21, 2017
• Actual Study Completion Date: Feb 21, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT [After 12 weeks of treatment]

Secondary Outcome Measures

1. 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT [16 weeks after treatment]

2. Change in central retinal thickness (CRT) [Weeks 12, 16, and 48]

3. Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity [Week 12, 16, and 48]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 51 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Calgary Retina Consultants	Calgary	Alberta	Canada	T2H 0C8
2	Alberta Retina Consultants	Edmonton	Alberta	Canada	T5H 0X5
3	Capital District Health Authority	Halifax	Nova Scotia	Canada	B3H 2Y9
4	St. Joseph's Centre for Ambulatory Services	Hamilton	Ontario	Canada	L8G 5E4
5	Hotel Dieu Hospital / Queen's	Kingston	Ontario	Canada	K7L 5G2
6	Ivey Eye Institute	London	Ontario	Canada	N6A 4V2
7	St. Michael's Hospital	Toronto	Ontario	Canada	M5B1W8
8	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
9	Saskatoon Retina Consultants	Saskatoon	Saskatchewan	Canada	S7S 0A7

Sponsors and Collaborators

• Unity Health Toronto

Investigators

• Principal Investigator: Michael H Brent, MD, FRCSC, Unity Health Toronto
• Principal Investigator: Rajeev Muni, MD, FRCSC, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT02002377
• Other Study ID Numbers: 01
• First Posted: Dec 5, 2013
• Last Update Posted: Apr 24, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Unity Health Toronto: Age Related Macular Degeneration, wet; aflibercept
• Additional relevant MeSH terms: Macular Degeneration; Aflibercept

Study Results

No Results Posted as of Apr 24, 2018