Neovascular Age-related Macular DegenerationPhase 4SALTNCT01958918
Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD
A Phase 4 study testing Ranibizumab and Aflibercept in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 68 sites in 10 countries.
Trial summary
The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Ranibizumab and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 712 participants
- Where
- 68 sitesin 10 countries
- Study dates
- 23 Oct 2013to 29 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visual impairment predominantly due to neovascular AMD Active
- Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion
Who cannot join
- Stroke or myocardial infarction less than 3 Months prior to study entry
- Active injection or inflammation of either eye at the time of study entry
- Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
Trial locations and contacts
68 sites in 10 countries.
68 sites in 10 countries
Germany34 sites
Novartis Investigative Site
Bad Rothenfelde, 49214
Novartis Investigative Site
Bayreuth, 95444
Novartis Investigative Site
Berlin, 10713
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Bonn, 53127
Novartis Investigative Site
Bremen, 28213
Novartis Investigative Site
Chemnitz, 09113
Novartis Investigative Site
Cologne, 50924
Novartis Investigative Site
Cologne, 50935
Novartis Investigative Site
Darmstadt, 64297
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Glauchau, 08371
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hagen, 58097
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
Mülheim, 45468
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Regensburg, Bavaria, 93053
Novartis Investigative Site
Siegburg, 53721
Novartis Investigative Site
Sulzbach, 66280
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Ulm, 89075
Novartis Investigative Site
Wolfsburg, 38442
Novartis Investigative Site
Würzburg, 97080
Portugal9 sites
Novartis Investigative Site
Braga, 4710243
Novartis Investigative Site
Coimbra, 3000-354
Novartis Investigative Site
Coimbra, 3030-163
Novartis Investigative Site
Lisbon, 1050-078
Novartis Investigative Site
Lisbon, 1050-085
Novartis Investigative Site
Porto, 4099-001
Novartis Investigative Site
Porto, 4200 319
Novartis Investigative Site
Vila Franca de Xira, 2600-009
Novartis Investigative Site
Vila Nova de Gaia, 4434 502
Austria6 sites
Novartis Investigative Site
Feldkirch, A-6807
Novartis Investigative Site
Graz, A-8036
Novartis Investigative Site
Linz, A-4020
Novartis Investigative Site
Salzburg, 5020
Novartis Investigative Site
Vienna, 1090
Novartis Investigative Site
Vienna, A-1130
France5 sites
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Dijon, 21034
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Paris, F-75571
Netherlands3 sites
Novartis Investigative Site
's-Hertogenbosch, 5223 GZ
Novartis Investigative Site
Amsterdam, 1105 AZ
Novartis Investigative Site
Nijmegen, 6500 HB
Switzerland3 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Fribourg, 1708
Novartis Investigative Site
Geneva, 1204
Belgium2 sites
Novartis Investigative Site
Laken, 1020
Novartis Investigative Site
Leuven, 3000
Denmark2 sites
Novartis Investigative Site
Glostrup Municipality, 2600
Novartis Investigative Site
Roskilde, 4000
Norway2 sites
Novartis Investigative Site
Arendal, 4800
Novartis Investigative Site
Oslo, 0264
Sweden2 sites
Novartis Investigative Site
Stockholm, 112 82
Novartis Investigative Site
Västerås, 72189
About this study
Official title: A 12-month, Phase IV, Randomized, Open Label, Multicenter Study to Compare Efficacy of 0.5 mg Ranibizumab Pro re Nata (PRN) Versus 2 mg Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability Till Month 6 of Treatment and Explore Functional Outcomes up to Month 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD)
The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.
Read the detailed description
Patients attended 14 scheduled study visits during 12 months.
- Being tested
- Ranibizumab, Aflibercept
- Keywords
- wet age-related macular degeneration (AMD), ranibizumab, aflibercept, Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis®
0.5 mg intravitreal injection
AfliberceptDrug
Also called Eylea®
2 mg intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | 1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity Receives: Drug: Ranibizumab |
| Aflibercept | Active comparator | 1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of the Absolute Values of CSRT Difference Month 3 to Month 6
The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.
Measured: Month 3, Month 4, Month 5, Month 6
Secondary outcomes (4)
Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12
Visual acuity was assessed in a sitting position with refraction using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. A higher score indicates better visual acuity. ETDRS scale ranges from 0-100 letters. A score of 65 to 70 letters represents a low to moderate visual acuity
Measured: Month 12
IREST at Month 12
Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.
Measured: Month 12
National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12
Vision-related quality of life was assessed by the patient using the National Eye Institute Visual Function Questionnaire. The scores of 12 subscales (general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision) were added together for a total (composite) score, which ranged from 0 to 100. A higher score indicates poorer function.
Measured: Month 12
Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)
Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.
Measured: Month 3 to Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study start23 Oct 2013
- Primary completion22 Nov 2016
- Study completion29 May 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 712 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
- NCT01958918
- Sponsor's protocol ID
- CRFB002ADE23
- Acronym
- SALT
- Status last verified
- Dec 2018
- First submitted
- 7 Oct 2013
- Last updated
- 21 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Phase IV, Randomized, Open Label, Multicenter Study to Compare Efficacy of 0.5 mg Ranibizumab Pro re Nata (PRN) Versus 2 mg Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability Till Month 6 of Treatment and Explore Functional Outcomes up to Month 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT01958918
- Acronym / sponsor ID
- SALT / CRFB002ADE23
- Keywords
- wet age-related macular degeneration (AMD), ranibizumab, aflibercept, Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2013 (actual)
- Primary completion
- 22 Nov 2016 (actual)
- Study completion
- 29 May 2017 (actual)
- First posted
- 9 Oct 2013 (estimated)
- Results
- Posted 21 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.
Detailed description
Patients attended 14 scheduled study visits during 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Ranibizumab1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity |
| Aflibercept | Active comparator | Drug: Aflibercept1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Visual impairment predominantly due to neovascular AMD Active
- Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion
Key exclusion criteria (3 listed)
- Stroke or myocardial infarction less than 3 Months prior to study entry
- Active injection or inflammation of either eye at the time of study entry
- Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
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 |
|---|---|---|
| RanibizumabAlso: Lucentis®0.5 mg intravitreal injection | Drug | Ranibizumab |
| AfliberceptAlso: Eylea®2 mg intravitreal injection | Drug | Aflibercept |
Primary outcome
Mean of the Absolute Values of CSRT Difference Month 3 to Month 6
Time frame: Month 3, Month 4, Month 5, Month 6
The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.
4 secondary outcomes
Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12
Time frame: Month 12
IREST at Month 12
Time frame: Month 12
National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12
Time frame: Month 12
Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)
Time frame: Month 3 to Month 6, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
68 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab and Aflibercept in people with Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 68 sites in 10 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 2 inclusion and 3 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Germany, Portugal, Austria, France, Netherlands and 5 more countries. 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 21 Mar 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?
Mean of the Absolute Values of CSRT Difference Month 3 to Month 6 (time frame: Month 3, Month 4, Month 5, Month 6). 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 21 Mar 2019.