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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005119-17 | EudraCT Number |
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To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 / Quality of Life | Experimental | Aflibercept treatment in subjects with diabetic macular edema (DME) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) | Drug | 2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 52 in NEI VFQ-25 Total Score | 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. | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Graz | Styria | 8036 | Austria | |||
Overall, 676 participants were screened. Of them, 116 participants did not complete screening: 100 failed screening; 8 withdrew, 1 had an adverse event, 1 was lost to follow-up and 6 were not assigned to treatment for other reasons. A total of 560 participants were assigned to treatment and 31 participants discontinued the study prematurely.
Study was conducted at multiple study centers in 14 countries, between 19 November 2015 (first participant first visit) and 09 August 2017 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept | Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2017 | Jul 26, 2018 |
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| Baseline, Week 52 |
| Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale | 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. | Baseline, Week 52 |
| Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score]) | 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. | Baseline, Week 52 |
| Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT) | 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. | Baseline, Week 52 |
| Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP) | 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. | Baseline, Week 52 |
| Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52 |
| Change From Baseline in Systolic Blood Pressure at Week 52 | Systolic blood pressure was measured in a consistent and standardized way according to locally established practice. | Baseline, Week 52 |
| Change From Baseline in Diastolic Blood Pressure at Week 52 | Diastolic blood pressure was measured in a consistent and standardized way according to locally established practice. | Baseline, Week 52 |
| Change From Baseline in Heart Rate at Week 52 | Heart rate was measured in a consistent and standardized way according to locally established practice. | Baseline, Week 52 |
| Change From Baseline in Body Temperature at Week 52 | Temperature was measured in a consistent and standardized way according to locally established practice. | Baseline, Week 52 |
| Vienna |
| 1090 |
| Austria |
| Vienna | 1140 | Austria |
| Halifax | Nova Scotia | B3H 2Y9 | Canada |
| London | Ontario | N6A 4V2 | Canada |
| Mississauga | Ontario | L4W 1W9 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M3C 0G9 | Canada |
| Montreal | Quebec | H4P 2S4 | Canada |
| Sherbrooke | Quebec | J1G 2V4 | Canada |
| Hradec Králové | 500 05 | Czechia |
| Prague | 100 34 | Czechia |
| Ústí nad Labem | 401 13 | Czechia |
| Créteil | 94010 | France |
| Marseille | 13285 | France |
| Darmstadt | Hesse | 64276 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Marburg | Hesse | 35043 | Germany |
| Göttingen | Lower Saxony | 37099 | Germany |
| Bonn | North Rhine-Westphalia | 53105 | Germany |
| Cologne | North Rhine-Westphalia | 50937 | Germany |
| Ludwigshafen am Rhein | Rhineland-Palatinate | 67063 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Dresden | Saxony | 01067 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Budapest | 1083 | Hungary |
| Budapest | 1106 | Hungary |
| Budapest | 1133 | Hungary |
| Debrecen | 4032 | Hungary |
| Pécs | 7621 | Hungary |
| Rome | Lazio | 00133 | Italy |
| Genoa | Liguria | 16132 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Turin | Piedmont | 10122 | Italy |
| Cagliari | Sardinia | 09124 | Italy |
| Sassari | Sardinia | 07100 | Italy |
| Florence | Tuscany | 50134 | Italy |
| Padova | Veneto | 35128 | Italy |
| Kaunas | LT-50009 | Lithuania |
| Vilnius | LT-08661 | Lithuania |
| Bydgoszcz | 85-631 | Poland |
| Gdansk | 80-809 | Poland |
| Katowice | 40-594 | Poland |
| Krakow | 31-501 | Poland |
| Lodz | 91-134 | Poland |
| Lublin | 20-079 | Poland |
| Poznan | 61-285 | Poland |
| Warsaw | 01-013 | Poland |
| Warsaw | 04-141 | Poland |
| Coimbra | 3000-548 | Portugal |
| Leiria | 2410-197 | Portugal |
| Lisbon | 1649-035 | Portugal |
| Porto | 4200-319 | Portugal |
| Vila Franca de Xira | 2600-178 | Portugal |
| Bratislava | 826 06 | Slovakia |
| Bratislava | 85107 | Slovakia |
| Nitra | 949 01 | Slovakia |
| Zvolen | 960 01 | Slovakia |
| Žilina | 01207 | Slovakia |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| San Cugat Del Vallès | Barcelona | 08190 | Spain |
| Albacete | 02006 | Spain |
| Barcelona | 08035 | Spain |
| Barcelona | 08036 | Spain |
| Valencia | 46014 | Spain |
| Bern | Switzerland |
| Geneva | 1204 | Switzerland |
| Southampton | Hampshire | SO16 6YD | United Kingdom |
| Camberley | Surrey | GU16 7UJ | United Kingdom |
| Guildford | Surrey | GU2 7XX | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |
| Sunderland | Tyne and Wear | SR2 9HP | United Kingdom |
| Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| London | EC1V 2PD | United Kingdom |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set (SAF) included all participants who received at least 1 injection of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept | Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety analysis set (SAF) included all participants who received at least 1 injection of study drug. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | SAF included all participants who received at least 1 injection of study drug. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | SAF included all participants who received at least 1 injection of study drug. | Count of Participants | Participants |
| |||||||||||||||
| Central Retinal Thickness (CRT) | The CRT was recorded at the study eye only. Participants received active treatment (intravitreal aflibercept) for the study eye and received close medical supervision. | 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. | Mean | Standard Deviation | microns |
| |||||||||||||
| Best Corrected Visual Acuity (BCVA) | The BCVA was recorded at the study eye only. Participants received active treatment (intravitreal aflibercept) for the study eye and received close medical supervision. 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. | 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. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| NEI VFQ-25 total score | 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, example: a score of 50 represents 50% of the highest possible score. | FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline national eye institute visual function questionnaire-25 (NEI VFQ-25) questionnaire. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| NEI VFQ-25 near activities subscale | 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 activities requiring near vision such as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. | 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. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| NEI VFQ-25 distant activities subscale | 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. | 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. | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Number of Participants with Diabetic Retinopathy Severity Score (DRSS) | The following severities are possible. 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Microaneurysms 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. | 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. | Count of Participants | Participants |
| ||||||||||||||
| Pre-injection Intraocular Pressure | SAF included all participants who received at least 1 injection of study drug. | Mean | Standard Deviation | millimeter of mercury (mmHg) |
| ||||||||||||||
| Systolic Blood Pressure | SAF included all participants who received at least 1 injection of study drug. | Mean | Standard Deviation | millimeter of mercury (mmHg) |
| ||||||||||||||
| Diastolic Blood Pressure | SAF included all participants who received at least 1 injection of study drug. | Mean | Standard Deviation | millimeter of mercury (mmHg) |
| ||||||||||||||
| Heart Rate | SAF included all participants who received at least 1 injection of study drug. | Mean | Standard Deviation | beats per minute (beats/min) |
| ||||||||||||||
| Body Temperature | SAF included all participants who received at least 1 injection of study drug. | Mean | Standard Deviation | celsius |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 52 in NEI VFQ-25 Total Score | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 52 |
|
|
| |||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 52 |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 52 |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score]) | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT) | 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. | 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. | Posted | Mean | 95% Confidence Interval | microns | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||
| Secondary | Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP) | 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. | 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. | Posted | Number | proportion of participants | Baseline, Week 52 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks | 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. | 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. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52 |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Systolic Blood Pressure at Week 52 | Systolic blood pressure was measured in a consistent and standardized way according to locally established practice. | 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. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Diastolic Blood Pressure at Week 52 | Diastolic blood pressure was measured in a consistent and standardized way according to locally established practice. | 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. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Heart Rate at Week 52 | Heart rate was measured in a consistent and standardized way according to locally established practice. | 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. | Posted | Mean | Standard Deviation | beats per minute (beats/min) | Baseline, Week 52 |
|
| ||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Body Temperature at Week 52 | Temperature was measured in a consistent and standardized way according to locally established practice. | 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. | Posted | Mean | Standard Deviation | celsius | Baseline, Week 52 |
|
|
From start of study treatment up to 30 days after the last injection of study treatment, up to week 52
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aflibercept | Participants were treated according to the EU-PI for treatment of DME for the first year of treatment and received 1 dose of 2 mg aflibercept injected IVT every 4 weeks for 5 consecutive doses, followed by dosing every 8 weeks thereafter until the end of the 52 week treatment period. | 5 | 560 | 66 | 560 | 0 | 560 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Anterior chamber inflammation | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Posterior capsule opacification | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Vitritis | Eye disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Boutonneuse fever | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Inflammation of wound | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Non-systematic Assessment |
| |
| Echocardiogram abnormal | Investigations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Influenza A virus test positive | Investigations | MedDRA (20.0) | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Umbilical hernia repair | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
| |
| Vitrectomy | Surgical and medical procedures | MedDRA (20.0) | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA (20.0) | Non-systematic Assessment |
|
Not provided
Center provides publication/presentation related to the Study Drug/Results 60 days prior to due date submission/presentation allowing Bayer review. Center receives notification within 45 days, Center reminds Bayer of Publication´s due date. Expected comments are within 60 days, if not Center to publish. Multi-center´s Results publication coordinates through Bayer Center publishes their Results provided overall results haven't been published within 18 months from Study completion for compliance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer AG | 1-888-8422937 | clinical-trials-contact@bayer.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 7, 2015 | Jul 26, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| 15 - DR questionable |
|
|
| 35 - Mild NPDR |
|
|
| 43 - Moderate NPDR |
|
|
| 47 - Moderately severe NPDR |
|
|
| 53 - Severe NPDR |
|
|
| 61 - Mild PDR |
|
|
| 65 - Moderate PDR |
|
|
| 71 - High-risk PDR |
|
|
| 90 - Cannot grade |
|
|
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|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Counts |
|---|
| Participants |
|
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|
|
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