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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02581995
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Macular Edema Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 19, 2015
Actual Primary Completion Date : August 9, 2017
Actual Study Completion Date : August 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Arm 1 / Quality of Life
Aflibercept treatment in subjects with diabetic macular edema (DME)
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale [ Time Frame: Baseline, Week 52 ]
    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.

  2. Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale [ Time Frame: Baseline, Week 52 ]
    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.

  3. 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 ]
    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.

  4. Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Week 52 ]
    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.

  5. 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 ]

    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.



Other Outcome Measures:
  1. Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks [ Time Frame: Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52 ]
    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.

  2. Change From Baseline in Systolic Blood Pressure at Week 52 [ Time Frame: Baseline, Week 52 ]
    Systolic blood pressure was measured in a consistent and standardized way according to locally established practice.

  3. Change From Baseline in Diastolic Blood Pressure at Week 52 [ Time Frame: Baseline, Week 52 ]
    Diastolic blood pressure was measured in a consistent and standardized way according to locally established practice.

  4. Change From Baseline in Heart Rate at Week 52 [ Time Frame: Baseline, Week 52 ]
    Heart rate was measured in a consistent and standardized way according to locally established practice.

  5. Change From Baseline in Body Temperature at Week 52 [ Time Frame: Baseline, Week 52 ]
    Temperature was measured in a consistent and standardized way according to locally established practice.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.)

Exclusion Criteria:

  • Pregnancy and lactation
  • Mismatch with inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581995


Locations
Show Show 76 study locations
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Statistical Analysis Plan  [PDF] May 4, 2017
Study Protocol  [PDF] September 7, 2015

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02581995    
Other Study ID Numbers: 17850
2014-005119-17 ( EudraCT Number )
First Posted: October 21, 2015    Key Record Dates
Results First Posted: October 10, 2018
Last Update Posted: October 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bayer:
Diabetic macular edema
Intravitreal injection
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases