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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Ranibizumab was supplied as a sterile solution in sealed glass vials.
Novartis Investigative Site
Adana, Turkey (Türkiye)
Novartis Investigational Site
Ankara, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey (Türkiye)
Novartis Investigative Site
Bursa, Turkey (Türkiye)
Novartis Investigative Site
Eskişehir, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, Turkey (Türkiye)
Novartis Investigative Site
Izmir, Turkey (Türkiye)
Novartis Investigative Site
Konya, Turkey (Türkiye)
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.
Time frame: 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.
Time frame: Baseline to Month 12
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.
Time frame: Baseline to Month 12
Number of Visits
Time frame: Baseline to Month 12
Follow-up Duration
Follow-up duration was defined as the number of days from Baseline to study discontinuation.
Time frame: Baseline to Month 12
Change in Central Retinal Thickness From Baseline to Month 12
Retinal thickness was measured using Optical Coherence Tomography (OCT).
Time frame: 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.
Time frame: Visits 2, 6, 9, 12, and 15 (up to 12 months)
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