Neovascular Age-related Macular DegenerationPhase 4SAFARINCT02161575
Safety and Efficacy of Switching From Aflibercept to Ranibizumab in Patients With nAMD
A Phase 4 study testing Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 28 sites in 2 countries.
Trial summary
AMD (Age Related Macular Degeneration) is the leading cause of severe visual loss and blindness registration in the UK . It is a disease which affects the retina (the nerve and blood vessel network at the back of the eye responsible for vision). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 28 Aug 2014to 14 Sep 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Best corrected visual acuity (BCVA) ≥23 ETDRS letters in study eye
- Evidence of active choroidal neovascularisation (CNV) involving the center of the fovea in study eye Patient subgroup specific inclusion criteria: - Group 1. Primary treatment failure
- Initiated treatment with aflibercept <130 days prior to the Screening Visit.
- No increase in BCVA (≥5 letters) since commencing treatment with aflibercept.
- Disease activity has never been controlled in the study eye after initiating aflibercept as defined by at least one of the following: evidence of unchanged or increasing retinal or subretinal fluid; new PED; unchanged or increasing size of preexisting PED.
- Group 2. Suboptimal treatment response
Show all 10Show fewer
- Aflibercept commenced ≥6 months prior to the Screening Visit.
- Received ≥3 aflibercept injections into the study eye within 6 months of the Screening Visit.
- Evidence of previous reduced disease activity (as defined by reduction of ≥50μm in Central Subfield Retinal Thickness on OCT) noted in the study eye after initiating aflibercept.
- At Screening Visit, disease activity has worsened (as defined by increasing retinal* or subretinal fluid, or new or increasing size of PED) in the study eye compared to prior visits.
Who cannot join
- History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the Screening visit.
- Uncontrolled blood pressure
- Evidence of bilateral active CNV during the Screening Period or at Baseline requiring bilateral antiVEGF injections.
- Prior intravitreal injection of ranibizumab or bevacizumab into the study eye and/or prior intravitreal injection of bevacizumab into the fellow eye.
- Cataract (if causing significant visual impairment), aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wet AMD (e.g. ocular histoplasmosis, pathologic myopia (≥8 dioptres)) at the time of Screening and Baseline.
- Irreversible structural damage involving the center of the fovea (e.g. advanced fibrosis or geographic atrophy) which in the opinion of the Investigator is sufficient to irreversibly impair visual acuity.
- Polypoidal choroidal vasculopathy (PCV), RPE tear, central serous retinopathy (CSR), or significant vitreomacular traction identified during Screening period or within 4 months of Baseline visit.
- Unable to obtain at Screening OCT images of sufficient quality to be analyzed
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United Kingdom22 sites
Novartis Investigative Site
Aberdeen, Scotland, AB25 2ZN
Novartis Investigative Site
Belfast, BT12 6BA
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Canterbury, Kent, CT1 3NG
Novartis Investigative Site
Darlington, Durham, DL3 6HX
Novartis Investigative Site
East Kilbride, G75 8RG
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
Glasgow, G12 OYN
Novartis Investigative Site
Great Yarmouth, NR31 6LA
Novartis Investigative Site
Harlow, Essex, CM20 1QX
Novartis Investigative Site
Harrogate, HG2 7SX
Novartis Investigative Site
Ipswich, Suffolk, IP4 5PD
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
London, EC1V 2PD
Novartis Investigative Site
London, NW1 5QH
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Oxford, OX3 9DU
Novartis Investigative Site
Southampton, SO16 6YD
Novartis Investigative Site
Sunderland, SR2 9HP
Novartis Investigative Site
Uxbridge, UB8 3NN
Novartis Investigative Site
York, YO31 8HE
Germany6 sites
Novartis Investigative Site
Bonn, 53127
Novartis Investigative Site
Karlsruhe, 76135
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Mühlheim, 45468
Novartis Investigative Site
München, 80336
Novartis Investigative Site
Münster, 48149
About this study
Official title: A Phase IV, Prospective, Open-label, Uncontrolled, European Study in Patients With Neovascular Age-related Macular Degeneration (nAMD), Evaluating the Efficacy and Safety of Switching From Intravitreal Aflibercept to Ranibizumab 0.5mg.
AMD (Age Related Macular Degeneration) is the leading cause of severe visual loss and blindness registration in the UK . It is a disease which affects the retina (the nerve and blood vessel network at the back of the eye responsible for vision). Patients can suffer with severe visual loss and have difficulties with every day tasks such as recognising faces, reading \& driving.
There are two variations of the disease, a 'dry' type \& a 'wet' type also known as neovascular AMD (nAMD). In wet/nAMD new vessels grow from the blood supply underneath the retina, in part due to higher than normal levels of a protein called Vascular Endothelial Growth Factor (VEGF). Since the introduction of drugs which block VEGF, visual outcomes for patients with wAMD have dramatically improved.
Read more
There are 2 widely used treatments; ranibizumab and aflibercept. Whilst the majority of patients have a successful outcome with treatment, many patients experience suboptimal response. This study evaluated if these patients experience a benefit from a switch to a different antiVEGF drug treatment.
In this study nAMD patients who are showing no or poor to response to treatment with aflibercept were switched to ranibizumab to assess if there is any benefit in terms of treatment outcomes.
Patients visited the hospital clinic 8 times over the 7 - 8 month study period. Monthly ranibizumab injections were given for the first 3 months, then monthly as required for the next 3 months.
- Being tested
- Ranibizumab
- Keywords
- Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD
- Medical subject headings
- Macular Degeneration, Vision Disorders, Geographic Atrophy, Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Intraveal injections of 0.5mg ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | All patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 90.
Measurement of the change in CSRT, determined by high definition optical coherence tomography (HD-OCT) after 3 monthly injections of ranibizumab. OCT is a non-invasive technique which can determine and measure thickness of the retina. A negative change from Baseline indicates an improvement (less retinal fluid and lower disease activity). Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 90
Secondary outcomes (14)
Change in Subfoveal Retinal Thickness (SRT) From Baseline to Day 180
Measurement of change in SRT from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 180
Measurement of change in CSRT from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Change in Central Subfield Retinal Volume (CSRV) From Baseline to Day 180
Measurement of change in CSRV from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Presence or absence of qualitative OCT parameter Intraretinal Fluid. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180
Presence or absence of qualitative OCT parameter Subretinal Fluid. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline to Day 180
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Presence or absence of qualitative OCT parameter Intraretinal/Subretinal Fluid Within the Central Subfield. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Presence or absence of qualitative OCT parameter Pigment Epithelial Detachments. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Number of Patients With Dry Retina Assessed at Baseline and Day 180
Presence or absence of qualitative OCT parameter Dry Retina. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Change in Maximum PED Height From Baseline to Day 180
Change from Baseline to Day 180 in Maximum Pigment Epithelial Detachment (PED) Height. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Change in Maximum PED Diameter From Baseline to Day 180
Change from Baseline to Day 180 in Maximum Pigment Epithelial Detachment (PED) Diameter. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Change in Maximum IRC Height From Baseline to Day 180
Change from Baseline to Day 180 in Maximum Intraretinal Cyst (IRC) Height. Data collected on the study eye were used for the evaluation of efficacy.
Measured: Baseline and Day 180
Change in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA was assessed as letters read and measured in a sitting position using subjective refraction and Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
Measured: Baseline, Day 90 and Day 180
Change in ETDRS Letters for Study Eye From Baseline to Day 180
Number of patients gaining at least 15 letters from Baseline to Day 180
Measured: Baseline and Day 180
Incidence of Ocular TEAEs in the Study Eye Reported by ≥2% Patients From Baseline to Day 180
Incidence of ocular Treatment Emergent Adverse Events (TEAEs) in the study eye reported by ≥2% patients by preferred term.
Measured: Baseline to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start28 Aug 2014
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161575
- Sponsor's protocol ID
- CRFB002AGB17
- Other IDs
- 2014-001085-10, 2014
- Acronym
- SAFARI
- Status last verified
- Feb 2019
- First submitted
- 10 Jun 2014
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gale RP, Pearce I, Eter N, Ghanchi F, Holz FG, Schmitz-Valckenberg S, Balaskas K, Burton BJL, Downes SM, Eleftheriadis H, George S, Gilmour D, Hamilton R, Lotery AJ, Patel N, Prakash P, Santiago C, Thomas S, Varma D, Walters G, Williams M, Wolf A, Zakri RH, Igwe F, Ayan F. Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study. Br J Ophthalmol. 2020 Apr;104(4):493-499. doi: 10.1136/bjophthalmol-2019-314251. Epub 2019 Aug 5.
PubMed 31383649
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Open-label, Uncontrolled, European Study in Patients With Neovascular Age-related Macular Degeneration (nAMD), Evaluating the Efficacy and Safety of Switching From Intravitreal Aflibercept to Ranibizumab 0.5mg.
- ClinicalTrials.gov ID
- NCT02161575
- Acronym / sponsor ID
- SAFARI / CRFB002AGB17
- Keywords
- Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, AMD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2014 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AMD (Age Related Macular Degeneration) is the leading cause of severe visual loss and blindness registration in the UK . It is a disease which affects the retina (the nerve and blood vessel network at the back of the eye responsible for vision). Patients can suffer with severe visual loss and have difficulties with every day tasks such as recognising faces, reading \& driving.
There are two variations of the disease, a 'dry' type \& a 'wet' type also known as neovascular AMD (nAMD). In wet/nAMD new vessels grow from the blood supply underneath the retina, in part due to higher than normal levels of a protein called Vascular Endothelial Growth Factor (VEGF). Since the introduction of drugs which block VEGF, visual outcomes for patients with wAMD have dramatically improved.
There are 2 widely used treatments; ranibizumab and aflibercept. Whilst the majority of patients have a successful outcome with treatment, many patients experience suboptimal response. This study evaluated if these patients experience a benefit from a switch to a different antiVEGF drug treatment.
In this study nAMD patients who are showing no or poor to response to treatment with aflibercept were switched to ranibizumab to assess if there is any benefit in terms of treatment outcomes.
Patients visited the hospital clinic 8 times over the 7 - 8 month study period. Monthly ranibizumab injections were given for the first 3 months, then monthly as required for the next 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: RanibizumabAll patients received 3 monthly intraveal injections of 0.5mg ranibizumab followed by monthly injections of ranibizumab 0.5mg for a further 3 months on a prn (as required) basis, as determined by the study doctor. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Best corrected visual acuity (BCVA) ≥23 ETDRS letters in study eye
- Evidence of active choroidal neovascularisation (CNV) involving the center of the fovea in study eye Patient subgroup specific inclusion criteria: - Group 1. Primary treatment failure
- Initiated treatment with aflibercept <130 days prior to the Screening Visit.
- No increase in BCVA (≥5 letters) since commencing treatment with aflibercept.
- Disease activity has never been controlled in the study eye after initiating aflibercept as defined by at least one of the following: evidence of unchanged or increasing retinal or subretinal fluid; new PED; unchanged or increasing size of preexisting PED.
Key exclusion criteria (8 listed)
- History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the Screening visit.
- Uncontrolled blood pressure
- Evidence of bilateral active CNV during the Screening Period or at Baseline requiring bilateral antiVEGF injections.
- Prior intravitreal injection of ranibizumab or bevacizumab into the study eye and/or prior intravitreal injection of bevacizumab into the fellow eye.
- Cataract (if causing significant visual impairment), aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wet AMD (e.g. ocular histoplasmosis, pathologic myopia (≥8 dioptres)) at the time of Screening and Baseline.
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 |
|---|---|---|
| RanibizumabIntraveal injections of 0.5mg ranibizumab | Drug | Ranibizumab |
Primary outcome
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 90.
Time frame: Baseline and Day 90
Measurement of the change in CSRT, determined by high definition optical coherence tomography (HD-OCT) after 3 monthly injections of ranibizumab. OCT is a non-invasive technique which can determine and measure thickness of the retina. A negative change from Baseline indicates an improvement (less retinal fluid and lower disease activity). Data collected on the study eye were used for the evaluation of efficacy.
14 secondary outcomes
Change in Subfoveal Retinal Thickness (SRT) From Baseline to Day 180
Time frame: Baseline and Day 180
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 180
Time frame: Baseline and Day 180
Change in Central Subfield Retinal Volume (CSRV) From Baseline to Day 180
Time frame: Baseline and Day 180
Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180
Time frame: Baseline and Day 180
Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180
Time frame: Baseline to Day 180
Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180
Time frame: Baseline and Day 180
Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180
Time frame: Baseline and Day 180
Number of Patients With Dry Retina Assessed at Baseline and Day 180
Time frame: Baseline and Day 180
Change in Maximum PED Height From Baseline to Day 180
Time frame: Baseline and Day 180
Change in Maximum PED Diameter From Baseline to Day 180
Time frame: Baseline and Day 180
Change in Maximum IRC Height From Baseline to Day 180
Time frame: Baseline and Day 180
Change in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Day 90 and Day 180
Change in ETDRS Letters for Study Eye From Baseline to Day 180
Time frame: Baseline and Day 180
Incidence of Ocular TEAEs in the Study Eye Reported by ≥2% Patients From Baseline to Day 180
Time frame: Baseline to Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31383649Gale RP, Pearce I, Eter N, Ghanchi F, Holz FG, Schmitz-Valckenberg S, Balaskas K, Burton BJL, Downes SM, Eleftheriadis H, George S, Gilmour D, Hamilton R, Lotery AJ, Patel N, Prakash P, Santiago C, Thomas S, Varma D, Walters G, Williams M, Wolf A, Zakri RH, Igwe F, Ayan F. Anatomical and functional outcomes following switching from aflibercept to ranibizumab in neovascular age-related macular degeneration in Europe: SAFARI study. Br J Ophthalmol. 2020 Apr;104(4):493-499. doi: 10.1136/bjophthalmol-2019-314251. Epub 2019 Aug 5.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 28 sites in 2 countries.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United Kingdom, Germany. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 90. (time frame: Baseline and Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161575, which also lists 1 linked publication.
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 15 Feb 2019.