A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema
NCT ID: NCT02850263
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
750 participants
OBSERVATIONAL
2016-07-05
2020-11-23
Brief Summary
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The main objectives of this observational cohort field study are to evaluate effectiveness of intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti vascular endothelial growth factor (anti-VEGF) treatment naïve patients with DMO in routine clinical practice in the United Kingdom.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1 / Anti-VEGF treatment naïve patients
Anti-VEGF treatment of naïve patients (who have not received any previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the United Kingdom.
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.
Cohort 2 / Anti-VEGF treatment non-naïve patients
Anti-VEGF treatment of non-naïve patients (who have received previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent \[Ophthalmologicals / Antineovascularisation agents (S01LA05)\] for the treatment of DMO by the patient.according to the prescribing physician.
Cohort 3 / Total study population
Anti-VEGF treatment naïve patients and anti-VEGF treatment non-naïve patients with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent \[Ophthalmologicals / Antineovascularisation agents (S01LA05)\] for the treatment of DMO by the patient.according to the prescribing physician.
Interventions
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Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent \[Ophthalmologicals / Antineovascularisation agents (S01LA05)\] for the treatment of DMO by the patient.according to the prescribing physician.
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent \[Ophthalmologicals / Antineovascularisation agents (S01LA05)\] for the treatment of DMO by the patient.according to the prescribing physician.
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with type 1 or 2 diabetes mellitus.
* Patients diagnosed with DMO with central involvement (defined as the area of the centre subfield of OCT) treated with intravitreal aflibercept (in accordance with routine practice).
* Patients for whom the decision to initiate treatment with intravitreal aflibercept was made as per the investigator's routine treatment practice and prior to study inclusion.
* Patients must provide written informed consent.
Exclusion Criteria
* Patients with contraindications as listed in the SmPC for intravitreal aflibercept.
* Patients with pre-planned cataract surgery during the observational period.
* Patients previously treated with intravitreal anti-VEGF within 28 days.
* Patients currently or previously treated with systemic anti-VEGF.
* Patients previously treated with intravitreal fluocinolone acetonide steroid.
* Patients participating in an investigational programme with interventions outside of routine clinical practice.
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Multiple Locations, , United Kingdom
Countries
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References
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Sivaprasad S, Ghanchi F, Kelly SP, Kotagiri A, Talks J, Scanlon P, McGoey H, Nolan A, Saddiq M, Napier J; DRAKO study group. Evaluation of standard of care intravitreal aflibercept treatment of diabetic macular oedema treatment-naive patients in the UK: DRAKO study 12-month outcomes. Eye (Lond). 2022 Jan;36(1):64-71. doi: 10.1038/s41433-021-01624-9. Epub 2021 Jul 9.
Sivaprasad S, Ghanchi F, Kelly SP, Kotagiri A, Talks J, Scanlon P, McGoey H, Nolan A, Saddiq M, Napier J. Evaluation of care with intravitreal aflibercept treatment for UK patients with diabetic macular oedema: DRAKO study 24-month real-world outcomes. Eye (Lond). 2023 Sep;37(13):2753-2760. doi: 10.1038/s41433-023-02409-y. Epub 2023 Mar 20.
Related Links
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Other Identifiers
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18058
Identifier Type: -
Identifier Source: org_study_id