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

NCT02002377 | Terminated Phase 4

• 1 other identifier: 01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 9

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

Keywords

Age Related Macular Degeneration, wet; aflibercept

Outcome Measures

Primary Outcomes (1)

• 'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT

  After 12 weeks of treatment

Secondary Outcomes (3)

• '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

Study Arms (1)

Aflibercept

EXPERIMENTAL

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

Interventions

Aflibercept 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

Aflibercept

Eligibility Criteria

• Age: 51 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>50 years
• 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
• Presence of intra or sub retinal fluid on SDOCT in the study eye
• 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
• ETDRS BCVA 20/30 and 20/320 (letter score of 78 to 25) in the study eye

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Presence of purely serous pigment epithelial detachment in the study eye
• Any scarring or fibrosis involving the center of the fovea in the study eye
• Prior ocular or systemic treatment/surgery for wet AMD other than ranibizumab IVI monthly (in study the eye)
• Prior prn or treat and extend treatment with ranibizumab IVI between 3 to 24 months before Baseline (Week 0) in the study eye
• Prior treatment with systemic anti-VEGF therapy within the last 6 months in the study eye
• History of vitreous hemorrhage within the last 6 months in the study eye
• Prior vitrectomy in the study eye
• History of retinal detachment in the study eye
• History of macular hole of stage 2 and above in the study eye
• Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
• Any intraocular or periocular surgery/invasive procedure during the previous 6 months except lid surgery in the study eye
• Prior trabeculectomy or other filtration surgery in the study eye
• Uncontrolled glaucoma (≥ 25mmHg despite treatment with anti-glaucoma medications) in the study eye
• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (9)

Calgary Retina Consultants

Calgary, Alberta, T2H 0C8, Canada

Location

Alberta Retina Consultants

Edmonton, Alberta, T5H 0X5, Canada

Location

Capital District Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

St. Joseph's Centre for Ambulatory Services

Hamilton, Ontario, L8G 5E4, Canada

Location

Hotel Dieu Hospital / Queen's

Kingston, Ontario, K7L 5G2, Canada

Location

Ivey Eye Institute

London, Ontario, N6A 4V2, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Saskatoon Retina Consultants

Saskatoon, Saskatchewan, S7S 0A7, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Michael H Brent, MD, FRCSC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Rajeev Muni, MD, FRCSC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: December 5, 2013
• Study Start: April 17, 2014
• Primary Completion: February 21, 2017
• Study Completion: February 21, 2017
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

CA (9)