Macular EdemaPhase 4AQUANCT02581995
Investigation of the Change of Vision-related Quality of Life in Subjects Treated With Aflibercept According to EU Label for DME.
A Phase 4 study testing Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) in people with Macular Edema, run by Bayer at 76 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 76 sitesin 14 countries
- Study dates
- 19 Nov 2015to 9 Aug 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or 2 diabetes mellitus
- Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
- Decrease in vision determined to be primarily the result of DME in the study eye
- BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
Who cannot join
- Pregnancy and lactation
- Mismatch with inclusion criteria
Trial locations and contacts
76 sites in 14 countries.
76 sites in 14 countries
Germany11 sites
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Cologne, North Rhine-Westphalia, 50937
Study site
Darmstadt, Hesse, 64276
Study site
Dresden, Saxony, 01067
Study site
Dresden, Saxony, 01307
Study site
Frankfurt am Main, Hesse, 60596
Study site
Göttingen, Lower Saxony, 37099
Study site
Leipzig, Saxony, 04103
Study site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
Marburg, Hesse, 35043
Italy9 sites
Study site
Cagliari, Sardinia, 09124
Study site
Florence, Tuscany, 50134
Study site
Genoa, Liguria, 16132
Study site
Milan, Lombardy, 20122
Study site
Milan, Lombardy, 20132
Study site
Padova, Veneto, 35128
Study site
Rome, Lazio, 00133
Study site
Sassari, Sardinia, 07100
Study site
Turin, Piedmont, 10122
Poland9 sites
Study site
Bydgoszcz, 85-631
Study site
Gdansk, 80-809
Study site
Katowice, 40-594
Study site
Krakow, 31-501
Study site
Lodz, 91-134
Study site
Lublin, 20-079
Study site
Poznan, 61-285
Study site
Warsaw, 01-013
Study site
Warsaw, 04-141
Canada7 sites
Study site
Halifax, Nova Scotia, B3H 2Y9
Study site
London, Ontario, N6A 4V2
Study site
Mississauga, Ontario, L4W 1W9
Study site
Montreal, Quebec, H4P 2S4
Study site
Ottawa, Ontario, K1H 8L6
Study site
Sherbrooke, Quebec, J1G 2V4
Study site
Toronto, Ontario, M3C 0G9
United Kingdom7 sites
Study site
Camberley, Surrey, GU16 7UJ
Study site
Guildford, Surrey, GU2 7XX
Study site
Leeds, West Yorkshire, LS9 7TF
Study site
London, EC1V 2PD
Study site
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Study site
Southampton, Hampshire, SO16 6YD
Study site
Sunderland, Tyne and Wear, SR2 9HP
Spain6 sites
Study site
Albacete, 02006
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
L'Hospitalet de Llobregat, Barcelona, 08907
Study site
San Cugat Del Vallès, Barcelona, 08190
Study site
Valencia, 46014
Hungary5 sites
Study site
Budapest, 1083
Study site
Budapest, 1106
Study site
Budapest, 1133
Study site
Debrecen, 4032
Study site
Pécs, 7621
Portugal5 sites
Study site
Coimbra, 3000-548
Study site
Leiria, 2410-197
Study site
Lisbon, 1649-035
Study site
Porto, 4200-319
Study site
Vila Franca de Xira, 2600-178
Slovakia5 sites
Study site
Bratislava, 826 06
Study site
Bratislava, 85107
Study site
Nitra, 949 01
Study site
Žilina, 01207
Study site
Zvolen, 960 01
Austria3 sites
Study site
Graz, Styria, 8036
Study site
Vienna, 1090
Study site
Vienna, 1140
Czechia3 sites
Study site
Hradec Králové, 500 05
Study site
Prague, 100 34
Study site
Ústí nad Labem, 401 13
About this study
Official title: Open-label Phase-4 Study to Examine the Change of Vision-related Quality of Life in Subjects With Diabetic Macular Edema (DME) During Treatment With Intravitreal Injections of 2 mg Aflibercept According to EU Label for the First Year of Treatment
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.
- Conditions
- Macular Edema
- Being tested
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Diabetic macular edema, Intravitreal injection
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Drug
2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 / Quality of Life | Experimental | Aflibercept treatment in subjects with diabetic macular edema (DME) Receives: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 52
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start19 Nov 2015
- Primary completion9 Aug 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581995
- Sponsor's protocol ID
- 17850
- Other IDs
- 2014-005119-17, 2014
- Acronym
- AQUA
- Status last verified
- Sep 2018
- First submitted
- 20 Oct 2015
- Last updated
- 10 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Phase-4 Study to Examine the Change of Vision-related Quality of Life in Subjects With Diabetic Macular Edema (DME) During Treatment With Intravitreal Injections of 2 mg Aflibercept According to EU Label for the First Year of Treatment
- ClinicalTrials.gov ID
- NCT02581995
- Acronym / sponsor ID
- AQUA / 17850
- Conditions
- Macular Edema
- Keywords
- Diabetic macular edema, Intravitreal injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 9 Aug 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 10 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 / Quality of Life | Experimental | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Aflibercept treatment in subjects with diabetic macular edema (DME) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or 2 diabetes mellitus
- Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
- Decrease in vision determined to be primarily the result of DME in the study eye
- BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
Key exclusion criteria (2 listed)
- Pregnancy and lactation
- Mismatch with inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection | Drug | Arm 1 / Quality of Life |
Primary outcome
Change From Baseline to Week 52 in NEI VFQ-25 Total Score
Time frame: Baseline, Week 52
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.
5 secondary outcomes
Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale
Time frame: Baseline, Week 52
Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale
Time frame: Baseline, Week 52
Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score])
Time frame: Baseline, Week 52
Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT)
Time frame: 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)
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
76 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) in people with Macular Edema, run by Bayer at 76 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in Germany, Italy, Poland, Canada, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 52 in NEI VFQ-25 Total Score (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.