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)

• ClinicalTrials.gov Identifier: NCT01148511
• Recruitment Status: Completed
• First Posted: June 22, 2010
• Results First Posted: May 20, 2013
• Last Update Posted: May 30, 2013
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease	Intervention/treatment	Phase
Age-related Macular Degeneration	Drug: Ranibizumab 0.5 mg	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: February 2010
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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. Results are reported in various categories of change in letter count.
2. Number of Visits [ Time Frame: Baseline to Month 12 ]
3. Follow-up Duration [ Time Frame: Baseline to Month 12 ]
   Follow-up duration was defined as the number of days from Baseline to study discontinuation.
4. Change in Central Retinal Thickness From Baseline to Month 12 [ Time Frame: Baseline to Month 12 ]
   Retinal thickness was measured using Optical Coherence Tomography (OCT).
5. Quality of Life [ Time Frame: Visits 2, 6, 9, 12, and 15 (up to 12 months) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01148511
• Other Study ID Numbers: CRFB002ATR01
• First Posted: June 22, 2010
• Results First Posted: May 20, 2013
• Last Update Posted: May 30, 2013
• Last Verified: May 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Macula degeneration; Ranibizumab; Choroidal neovascularisation; Treat and extend; Treat and observe

Additional relevant MeSH terms:

Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic; Retinal Degeneration; Retinal Diseases; Eye Diseases; Metaplasia; Pathologic Processes; Choroid Diseases; Uveal Diseases; Ranibizumab; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents