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Intravitreal aflibercept has been approved for the treatment of visual impairments due to diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) | Drug | Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept | BCVA (Best Corrected Visual Acuity): process to measure with the help of a retinoscope, auto-refractor or phoropter how much power is needed to bring the eye to normal, perfectly focused vision) when performed in addition to that at baseline and 12 months. ETDRS Chart: charts imprinted with lines of letters decreasing in size from largest on top to smallest on the bottom to determine visual acuity. | Baseline and 12 months |
| Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept | Baseline and 24 months | |
| Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients with a diagnosis of diabetic macular oedema with central involvement will be enrolled after the decision for treatment with intravitreal aflibercept has been made.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34244670 | Result | 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. | |
| 36941402 |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05) | Drug | 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) | Drug | 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. |
|
| Baseline and 24 months |
| Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept | Baseline, 12 and 24 months |
| Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept differentiated by BCVA baseline characteristics | Baseline, 12 and 24 months |
| Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics | Baseline, 12 and 24 months |
| Proportion (%) of patients discontinuing intravitreal aflibercept treatment | Baseline, 12 and 24 months |
| Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment | Baseline |
| The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment | Baseline |
| Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss | Baseline, 12 and 24 months |
| Proportion (%) of sites that adhere to their stated treatment protocol | 12 and 24 months |
| Change in QoL score measured by NEI VFQ-25 | Baseline, 12 and 24 months |
| Change in macular volume | Baseline, 12 and 24 months |
| Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters | Baseline, 12 and 24 months |
| Change in non-refracted visual acuity (VA).for the fellow eye | Baseline, 12 and 24 months |
| Number of DMO treatments required for the fellow eye | Baseline, 12 and 24 months |
| Number of visits performed (resources) to assess the fellow eye | Baseline, 12 and 24 months |
| Number of clinical procedures performed (resources) to assess the fellow eye | Baseline, 12 and 24 months |
| Number of adverse events as a measure of safety and tolerability | 24 months |
| Reason for discontinuation of intravitreal aflibercept treatment | Baseline, 12 and 24 months |
| Change in Central Subfield Thickness (CST) of the fellow eye | Baseline, 12 and 24 months |
| Type of DMO treatments required for the fellow eye | Baseline, 12 and 24 months |
| 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. |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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