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) (SALUTE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01148511
First received: June 21, 2010
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Age-related Macular Degeneration
Drug: Ranibizumab 0.5 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in Best-Corrected Visual Acuity (logMAR) From Baseline to Month 12 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
  • Follow-up Duration [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    Retinal thickness was measured using Optical Coherence Tomography (OCT).

  • Quality of Life [ Time Frame: Visits 2, 6, 9, 12, and 15 (up to 12 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 99
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treat and Extend
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.
Drug: Ranibizumab 0.5 mg
Ranibizumab was supplied as a sterile solution in sealed glass vials.
Other Name: Lucentis
Active Comparator: Treat and Observe
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.
Drug: Ranibizumab 0.5 mg
Ranibizumab was supplied as a sterile solution in sealed glass vials.
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148511

Locations
Turkey
Novartis Investigative Site
Adana, Turkey
Novartis Investigational Site
Ankara, Turkey
Novartis Investigative Site
Ankara, Turkey
Novartis Investigative Site
Bursa, Turkey
Novartis Investigative Site
Eskişehir, Turkey
Novartis Investigative Site
İstanbul, Turkey
Novartis Investigative Site
İzmir, Turkey
Novartis Investigative Site
Konya, Turkey
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01148511     History of Changes
Other Study ID Numbers: CRFB002ATR01
Study First Received: June 21, 2010
Results First Received: April 2, 2013
Last Updated: May 23, 2013
Health Authority: Turkey: Sisli Etfal Training and Research Hospital Clinical Research Ethics Committee
Turkey: Uludag University Clinical Research Ethics Committee
Turkey: Istanbul Bilim University Clinical Research Ethics Committee
Turkey: Istanbul University Istanbul Medical Faculty Clinical Research Ethics Committee
Turkey: Istanbul University Cerrahpaşa Medical Faculty Clinical Research Ethics Committee
Turkey: Ankara University Clinical Research Ethics Committee
Turkey: Ege University Clinical Research Ethics Committee
Turkey: Dokuz Eylul University Clinical Research Ethics Committee
Turkey: Cukurova University Clinical Research Ethics Committee
Turkey: Konya Selcuk University Clinical Research Ethics Committee
Turkey: Gazi University Clinical Research Ethics Committee
Turkey: Osmangazi University Clinical Research Ethics Committee

Keywords provided by Novartis:
Macula degeneration
Ranibizumab
Choroidal neovascularisation
Treat and extend
Treat and observe

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on September 18, 2014