Back to resultsComparison 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) (SALUTE)
Primary Purpose
Age-related Macular Degeneration
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ranibizumab 0.5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Macula degeneration, Ranibizumab, Choroidal neovascularisation, Treat and extend, Treat and observe
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigational Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treat and Extend
Treat and Observe
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Number of Visits
Follow-up Duration
Follow-up duration was defined as the number of days from Baseline to study discontinuation.
Change in Central Retinal Thickness From Baseline to Month 12
Retinal thickness was measured using Optical Coherence Tomography (OCT).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01148511
Brief 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 Age-related Macular Degeneration (AMD)
Acronym
SALUTE
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
Macula degeneration, Ranibizumab, Choroidal neovascularisation, Treat and extend, Treat and observe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treat and Extend
Arm Type
Experimental
Arm Description
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.
Arm Title
Treat and Observe
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5 mg
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab was supplied as a sterile solution in sealed glass vials.
Primary Outcome Measure Information:
Title
Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12
Description
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.
Time Frame
Baseline to Month 12
Title
Change in Letter Count From Baseline to Month 12
Description
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.
Time Frame
Baseline to Month 12
Secondary Outcome Measure Information:
Title
Letter Count From Baseline to Month 12
Description
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.
Time Frame
Baseline to Month 12
Title
Number of Visits
Time Frame
Baseline to Month 12
Title
Follow-up Duration
Description
Follow-up duration was defined as the number of days from Baseline to study discontinuation.
Time Frame
Baseline to Month 12
Title
Change in Central Retinal Thickness From Baseline to Month 12
Description
Retinal thickness was measured using Optical Coherence Tomography (OCT).
Time Frame
Baseline to Month 12
Title
Quality of Life
Description
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.
Time Frame
Visits 2, 6, 9, 12, and 15 (up to 12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Adana
Country
Turkey
Facility Name
Novartis Investigational Site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Bursa
Country
Turkey
Facility Name
Novartis Investigative Site
City
Eskişehir
Country
Turkey
Facility Name
Novartis Investigative Site
City
İstanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
İzmir
Country
Turkey
Facility Name
Novartis Investigative Site
City
Konya
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
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)
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