Age-related Macular DegenerationPhase 4SALUTENCT01148511
Comparison of Safety, Effectiveness and Quality of Life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to Age-related Macular Degeneration (AMD)
A Phase 4 study testing Ranibizumab 0.5 mg in people with Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 8 sites in Turkey (Türkiye).
Trial summary
The purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- Ranibizumab 0.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 8 sitesTurkey (Türkiye)
- Study dates
- Feb 2010to Apr 2012
- 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
- Male or female patients over the age of 50.
- Patients with primary, secondary, or recurrent subfoveal choroidal neovascularization (CNV) to AMD with classic, minimal classic, or occult lesions.
- Patients with CNV area ≥ %50 of the total lesion.
- Total lesion area ≤ 12 disc areas for minimal classic/occult lesions and ≤ 9 disc areas for the classic lesions.
- Best-corrected visual acuity (BCVA) score between 73 and 34 letters in the study eye.
Who cannot join
- BCVA < 34 letters.
- Patients using anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, corticosteroids, or protein kinase C inhibitors, etc) or inclusion in another trial (for any eye).
- Verteporphin, external radiational therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy application to the eye before the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Turkey (Türkiye)8 sites
Novartis Investigative Site
Adana
Novartis Investigational Site
Ankara
Novartis Investigative Site
Ankara
Novartis Investigative Site
Bursa
Novartis Investigative Site
Eskişehir
Novartis Investigative Site
Istanbul
Novartis Investigative Site
Izmir
Novartis Investigative Site
Konya
About this study
Official title: Comparison of Safety, Effectiveness, and Quality-of-life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to AMD
The purpose of the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual loss of more than 5 letters with monthly control (Treat and Observe). The second treatment regimen was 1 injection each month for 3 months and than extending the control period if the macula is dry during the monthly control (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the number of ranibizumab injections, the number of patient visits, the risk of adverse events due to the intravitreal injections, and policlinic occupation number could all be reduced.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Ranibizumab 0.5 mg
- Keywords
- Macula degeneration, Ranibizumab, Choroidal neovascularisation, Treat and extend, Treat and observe
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5 mgDrug
Also called Lucentis
Ranibizumab was supplied as a sterile solution in sealed glass vials.
| Study group | Role | What they receive |
|---|---|---|
| Treat and Extend | Experimental | Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over. Receives: Drug: Ranibizumab 0.5 mg |
| Treat and Observe | Active comparator | Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later. Receives: Drug: Ranibizumab 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12
Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Measured: Baseline to Month 12
Change in Letter Count From Baseline to Month 12
Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.
Measured: Baseline to Month 12
Secondary outcomes (5)
Letter Count From Baseline to Month 12
Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Results are reported in various categories of change in letter count.
Measured: Baseline to Month 12
Number of Visits
Measured: Baseline to Month 12
Follow-up Duration
Follow-up duration was defined as the number of days from Baseline to study discontinuation.
Measured: Baseline to Month 12
Change in Central Retinal Thickness From Baseline to Month 12
Retinal thickness was measured using Optical Coherence Tomography (OCT).
Measured: Baseline to Month 12
Quality of Life
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Visits 2, 6, 9, 12, and 15. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.
Measured: Visits 2, 6, 9, 12, and 15 (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2012
- Study completionApr 2012
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 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
- None (open label)
- Enrolment
- 99 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
- NCT01148511
- Sponsor's protocol ID
- CRFB002ATR01
- Acronym
- SALUTE
- Status last verified
- May 2013
- First submitted
- 21 Jun 2010
- Last updated
- 30 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety, Effectiveness, and Quality-of-life Outcomes Between Labeled Versus "Treat and Extend" Regimen in Turkish Patients With Choroidal Neovascularisation Due to AMD
- ClinicalTrials.gov ID
- NCT01148511
- Acronym / sponsor ID
- SALUTE / CRFB002ATR01
- Conditions
- Age-related Macular Degeneration
- Keywords
- Macula degeneration, Ranibizumab, Choroidal neovascularisation, Treat and extend, Treat and observe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 20 May 2013
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 the study was to compare 2 treatment regimens for patients suffering from choroidal neovascularisation secondary to age-related macular degeneration (AMD). The first treatment regimen was the approved AMD treatment of 1 injection each month for 3 months and than re-treatment of patients who have a visual loss of more than 5 letters with monthly control (Treat and Observe). The second treatment regimen was 1 injection each month for 3 months and than extending the control period if the macula is dry during the monthly control (Treat and Extend). If the "Treat and Extend" regimen is found effective and safe, the number of ranibizumab injections, the number of patient visits, the risk of adverse events due to the intravitreal injections, and policlinic occupation number could all be reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treat and Extend | Experimental | Drug: Ranibizumab 0.5 mgPatients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over. |
| Treat and Observe | Active comparator | Drug: Ranibizumab 0.5 mgPatients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients over the age of 50.
- Patients with primary, secondary, or recurrent subfoveal choroidal neovascularization (CNV) to AMD with classic, minimal classic, or occult lesions.
- Patients with CNV area ≥ %50 of the total lesion.
- Total lesion area ≤ 12 disc areas for minimal classic/occult lesions and ≤ 9 disc areas for the classic lesions.
- Best-corrected visual acuity (BCVA) score between 73 and 34 letters in the study eye.
Key exclusion criteria (4 listed)
- BCVA < 34 letters.
- Patients using anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, corticosteroids, or protein kinase C inhibitors, etc) or inclusion in another trial (for any eye).
- Verteporphin, external radiational therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy application to the eye before the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Ranibizumab 0.5 mgAlso: LucentisRanibizumab was supplied as a sterile solution in sealed glass vials. | Drug | Treat and Extend, Treat and Observe |
Primary outcome
Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12
Time frame: Baseline to Month 12
Best corrected visual acuity (BCVA) was assessed in the study eye. BCVA measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. Each letter on the chart has a score value of 0.02 log units. Since there are 5 letters per line, the total score for a line on the logMAR chart represents a change of 0.1 log units. The formula for calculating the logMAR BCVA score is: 0.1 + logMAR value of the best line read - 0.02 x number of letters read. A lower BCVA score indicates better vision. A negative change score indicates improvement.
Change in Letter Count From Baseline to Month 12
Time frame: Baseline to Month 12
Letter count was assessed in the study eye. Measurements were made using the logarithm of the minimum angle of resolution (logMAR) visual acuity testing charts. A higher letter count score indicates better vision. A negative change score indicates improvement.
5 secondary outcomes
Letter Count From Baseline to Month 12
Time frame: Baseline to Month 12
Number of Visits
Time frame: Baseline to Month 12
Follow-up Duration
Time frame: Baseline to Month 12
Change in Central Retinal Thickness From Baseline to Month 12
Time frame: Baseline to Month 12
Quality of Life
Time frame: Visits 2, 6, 9, 12, and 15 (up to 12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
8 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 Ranibizumab 0.5 mg in people with Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 8 sites in Turkey (Türkiye).
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 5 inclusion and 4 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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Turkey (Türkiye). 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 20 May 2013). 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 Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12 (time frame: Baseline to Month 12). The study lists 2 primary outcomes in all. 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 30 May 2013.