Age Related Macular DegenerationPhase 4SHIFT-2NCT02002377
Intravitreal Aflibercept in Wet Age Related Macular Degeneration Patients With an Incomplete Response to Routine Ranibizumab Injections
A Phase 4 study testing Aflibercept in people with Age Related Macular Degeneration, run by Unity Health Toronto at 9 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 9 sitesCanada
- Study dates
- 17 Apr 2014to 21 Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Note: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
- Scheduled for intraocular surgery during the study period in the study eye
- Concurrent retinal disease (i.e. diabetic retinopathy, retinal vein occlusion, retinal detachment, uveitis) in the study eye
- History of ocular or periocular infection/inflammation in the study eye within the last 4 weeks of screening
- Pregnant or breastfeeding
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Calgary Retina Consultants
Calgary, Alberta, T2H 0C8
Alberta Retina Consultants
Edmonton, Alberta, T5H 0X5
Capital District Health Authority
Halifax, Nova Scotia, B3H 2Y9
St. Joseph's Centre for Ambulatory Services
Hamilton, Ontario, L8G 5E4
Hotel Dieu Hospital / Queen's
Kingston, Ontario, K7L 5G2
Ivey Eye Institute
London, Ontario, N6A 4V2
Saskatoon Retina Consultants
Saskatoon, Saskatchewan, S7S 0A7
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
About this study
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
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
- Being tested
- Aflibercept
- Keywords
- Age Related Macular Degeneration, wet, aflibercept
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
Measured: After 12 weeks of treatment
Secondary outcomes (3)
'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
Measured: 16 weeks after treatment
Change in central retinal thickness (CRT)
Measured: Weeks 12, 16, and 48
Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity
Measured: Week 12, 16, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study start17 Apr 2014
- Primary completion21 Feb 2017
- Study completion21 Feb 2017
Why it stopped: Inadequate enrollment due to investigational product becoming newly available on the Canadian market soon after study start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael H Brent, MD, FRCSC, Principal investigator, Unity Health TorontoRajeev Muni, MD, FRCSC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002377
- Sponsor's protocol ID
- 01
- Acronym
- SHIFT-2
- Status last verified
- Apr 2018
- First submitted
- 29 Nov 2013
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02002377
- Acronym / sponsor ID
- SHIFT-2 / 01
- Conditions
- Age Related Macular Degeneration
- Keywords
- Age Related Macular Degeneration, wet, aflibercept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment due to investigational product becoming newly available on the Canadian market soon after study start
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 17 Apr 2014 (actual)
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Experimental | Drug: AfliberceptAflibercept 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 |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Note: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptAflibercept 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 |
Primary outcome
'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
Time frame: After 12 weeks of treatment
3 secondary outcomes
'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT
Time frame: 16 weeks after treatment
Change in central retinal thickness (CRT)
Time frame: Weeks 12, 16, and 48
Change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity
Time frame: Week 12, 16, and 48
Results and safety
The study was stopped early (reason given: Inadequate enrollment due to investigational product becoming newly available on the Canadian market soon after study start). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Brent, MD, FRCSC principal investigator
Unity Health Toronto
Rajeev Muni, MD, FRCSC principal investigator
Unity Health Toronto
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept in people with Age Related Macular Degeneration, run by Unity Health Toronto at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment due to investigational product becoming newly available on the Canadian market soon after study start). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
'OCT defined success' defined by no presence of intra or sub retinal fluid on SDOCT (time frame: After 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.