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

NCT ID: NCT02002377

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-17
• Study Completion Date: 2017-02-21

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.

Conditions

Age Related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Aflibercept

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Brent, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Rajeev Muni, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Saskatoon Retina Consultants

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id