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)

Age-related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148511
• Other study ID #: CRFB002ATR01
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2010
• Last updated: May 23, 2013
• Start date: February 2010
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Sisli Etfal Training and Research Hospital Clinical Research Ethics CommitteeTurkey: Uludag University Clinical Research Ethics CommitteeTurkey: Istanbul Bilim University Clinical Research Ethics CommitteeTurkey: Istanbul University Istanbul Medical Faculty Clinical Research Ethics CommitteeTurkey: Istanbul University Cerrahpasa Medical Faculty Clinical Research Ethics CommitteeTurkey: Ankara University Clinical Research Ethics CommitteeTurkey: Ege University Clinical Research Ethics CommitteeTurkey: Dokuz Eylul University Clinical Research Ethics CommitteeTurkey: Cukurova University Clinical Research Ethics CommitteeTurkey: Konya Selcuk University Clinical Research Ethics CommitteeTurkey: Gazi University Clinical Research Ethics CommitteeTurkey: Osmangazi University Clinical Research Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• Ranibizumab 0.5 mg
Ranibizumab was supplied as a sterile solution in sealed glass vials.

Locations

Country	Name	City	State
Turkey	Novartis Investigative Site	Adana
Turkey	Novartis Investigational Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Bursa
Turkey	Novartis Investigative Site	Eskisehir
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Month 12	No
Primary	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.	Baseline to Month 12	No
Secondary	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.	Baseline to Month 12	No
Secondary	Number of Visits		Baseline to Month 12	No
Secondary	Follow-up Duration	Follow-up duration was defined as the number of days from Baseline to study discontinuation.	Baseline to Month 12	No
Secondary	Change in Central Retinal Thickness From Baseline to Month 12	Retinal thickness was measured using Optical Coherence Tomography (OCT).	Baseline to Month 12	No
Secondary	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.	Visits 2, 6, 9, 12, and 15 (up to 12 months)	No