The study investigates whether patients treated for neovascular (wet) age-related macular degeneration (AMD), with intravitreal injection with bevacizumab (Avastin) after two years need more injections with retained therapy response compared to patients being treated with intravitreal injection with aflibercept (Eylea). The study also aims to evaluate if there is a difference in best-corrected visual acuity, macular thickness, recurrence interval, durability, cost efficiency, as well as vision-related quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
402
25 mg/ml
40 mg/ml
Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology
Mölndal, Sweden
Number of injections
Number of intravitreal injections
Time frame: Two years
Best-corrected visual acuity (BCVA), distance
ETDRS
Time frame: Two years
Best-corrected visual acuity (BCVA), near
LIX
Time frame: Two years
Macular thickness (Central Retinal Thickness; CRT)
μm
Time frame: Two years
Intraocular pressure (IOP)
mmHg
Time frame: Two years
Recurrence interval
Maximum number of weeks from last injection to relapse, at first and last relapse.
Time frame: Two years
Durability
Longest inactive interval detected (number of weeks).
Time frame: Two years
Cost efficiency
Quality-adjusted life years (QALY), cost-per-QALY is measured with the EuroQol-5 Dimension (EQ-5D) questionnaire. EQ-5D consists of five subscales: mobility, self-care, usual activities, discomfort/pain and anxiety/depression. The subscales measure different aspects of health and well-being where the subject is asked to rank each subscale from 1 (no problems) to 3 (major problems). These answers are converted to a score between 0 (=death) to 1 (=full health). The subscales are converted to a weighted mean which ranges from 0 (death) to 1 (full health). Negative values may exists for conditions worse than death. The weighting differs between geographic areas; for Sweden, the UK weighting scale is used.
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Time frame: Two years
Vision-related quality of life
National Eye Institute Visual Functioning Questionnaire -25 (NEI VFQ-25) questionnaire is based on 25 questions (items) where the subject is asked questions on visual function, daily activities and social consequences of visual function. The questions have answers on a 5- or 6-grade scale which are converted to a scale from 0 (no function/worst consequence) to 100 (no problems). The 25 items are clustered into 12 subscales. Items within each subscale are averaged to create the subscale scores according to the NEI VFQ-25 scoring algorithm. In addition, a composite score for all 12 subscales are created as an average of these. Minimum score is 0 and maximum score is 100 for each item, subscale and the composite score.
Time frame: Two years
Cost-benefit
The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It represents the average incremental cost associated with 1 additional unit of the measure of effect and is given in Euro.
Time frame: Two years