Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.

National eye institute 25-item visual function questionnaire (NEI VFQ-25) is a condition-specific measure which was designed to capture the specific impact of vision loss on health-related quality of life (HRQoL). The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the NEI VFQ-25 Scoring Algorithm - August 2000. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.

Time frame: Baseline, Week 52

Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.

Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group 1985) starting at 4 meters. The values might range from 0 to 100. A higher score represents better functioning.

Time frame: Baseline, Week 52

Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.

Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT). For all visits where the OCT procedure was scheduled, images were captured and read by the investigator. All OCTs were electronically archived at the study sites as part of the source documentation.

Time frame: Baseline, Week 52

Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire. Participants who were evaluable for this measure at given time point for the arm were included in the category.

NEI VFQ-25 is a condition-specific measure which was designed to capture the specific impact of vision loss on HRQoL. The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the NEI VFQ-25 Scoring Algorithm - August 2000. Items within each sub-scale are averaged together to create the 12 sub-scale Scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Sub-scales with at least one item answered can be used to generate a sub-scale score. Hence, scores represent the average for all items in the subscale that the respondent answered. The NEI VFQ-25 distant activities subscale was scored from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. Distant activities are defined as activities requiring distance vision, such as recognizing faces or reading street signs.

Time frame: Baseline, Week 52

Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.

NEI VFQ-25 is a condition-specific measure which was designed to capture the specific impact of vision loss on HRQoL. The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the NEI VFQ-25 Scoring Algorithm - August 2000. Items within each sub-scale are averaged together to create the 12 sub-scale Scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Sub-scales with at least one item answered can be used to generate a sub-scale score. Hence, scores represent the average for all items in the subscale that the respondent answered.The NEI VFQ-25 near activities subscale was scored from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.

Time frame: Baseline, Week 52

Population: FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.

The ETDRS DRSS was assessed by FP according to the following scale for both eyes. The following severities are possible. 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.

Time frame: Baseline, Week 52

Population: Subjects in the FAS with gradable baseline and Week 52 FP and a DRSS of less than (\<) 61 at baseline. Participants who were evaluable for this measure at given time point for the arm were included in the category.

Temperature was measured in a consistent and standardized way according to locally established practice.

Time frame: Baseline, Week 52

Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.

Diastolic blood pressure was measured in a consistent and standardized way according to locally established practice.

Time frame: Baseline, Week 52

Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.

Heart rate was measured in a consistent and standardized way according to locally established practice.

Time frame: Baseline, Week 52

Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.

Intraocular pressure (IOP) was measured using applanation tonometry Goldmann, Tonopen or approved alternative). The same method of intraocular pressure measurement was used in each participant throughout the study. For the measurement of intraocular pressure, a local anesthetic combined with fluorescein was applied topically to the eye being tested (example: one drop of oxybuprocain plus fluorescein). In the below table, pre-injection intraocular pressure for study eye was reported.

Time frame: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52

Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time points for the arm were included in the categories.

Systolic blood pressure was measured in a consistent and standardized way according to locally established practice.

Time frame: Baseline, Week 52

Population: SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.