A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Macular Edema	Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) Other Names Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05) Other Names Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05) Other Names	N/A

Tracking Information

First Submitted Date	May 19, 2016
Last Update Posted Date	February 12, 2018
Actual Start Date	July 05, 2016
Anticipated Completion Date	December 30, 2019
Actual Primary Completion Date	December 30, 2018
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept [Time Frame: Baseline and 12 months]

• Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept [Time Frame: Baseline and 12 months]

  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.

Original Primary Outcome Measures

Current Secondary Outcome Measures

• Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept [Time Frame: 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 [Time Frame: Baseline and 24 months]

• Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept [Time Frame: 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 [Time Frame: Baseline, 12 and 24 months]

• Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics [Time Frame: Baseline, 12 and 24 months]

• Proportion (%) of patients discontinuing intravitreal aflibercept treatment [Time Frame: Baseline, 12 and 24 months]

• Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment [Time Frame: Baseline]

• The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment [Time Frame: Baseline]

• Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss [Time Frame: Baseline, 12 and 24 months]

• Proportion (%) of sites that adhere to their stated treatment protocol [Time Frame: 12 and 24 months]

• Change in QoL score measured by NEI VFQ-25 [Time Frame: Baseline, 12 and 24 months]

• Change in macular volume [Time Frame: Baseline, 12 and 24 months]

• Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters [Time Frame: Baseline, 12 and 24 months]

• Change in non-refracted visual acuity (VA).for the fellow eye [Time Frame: Baseline, 12 and 24 months]

• Number of DMO treatments required for the fellow eye [Time Frame: Baseline, 12 and 24 months]

• Number of visits performed (resources) to assess the fellow eye [Time Frame: Baseline, 12 and 24 months]

• Number of clinical procedures performed (resources) to assess the fellow eye [Time Frame: Baseline, 12 and 24 months]

• Number of adverse events as a measure of safety and tolerability [Time Frame: 24 months]

• Reason for discontinuation of intravitreal aflibercept treatment [Time Frame: Baseline, 12 and 24 months]

• Change in Central Subfield Thickness (CST) of the fellow eye [Time Frame: Baseline, 12 and 24 months]

• Type of DMO treatments required for the fellow eye [Time Frame: Baseline, 12 and 24 months]

Original Secondary Outcome Measures

Study Design

Brief Title	A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema
Official Title	An Observational Study to Assess the Effectiveness of Intravitreal Aflibercept in Routine Clinical Practice tn Patients With Visual Impairment Due to Diabetic Macular Oedema (DMO)
Brief Summary	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.
Detailed Description
Study Type	Observational
Study Phase	N/A
Estimated Enrollment	750
Allocation	Not Available
Interventional Model	Not Available
Masking	Not Available
Primary Purpose	Not Available
Conditions	Macular Edema
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	Non-Probability Sample
Study Population	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.
Intervention	Drug: 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. Other Names Drug: 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. Other Names Drug: 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. Other Names
Study Groups/Cohorts	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. 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.
Study Arms	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. Drug : 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. Drug : 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. Drug : 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.

Arm	Intervention/Treatment
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.	Drug : 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.	Drug : 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.	Drug : 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.

Recruitment Information

Recruitment Status:	Recruiting
Enrollment	750
Completion Date	December 30, 2019
Eligibility Criteria:	Inclusion Criteria: - Patients aged 18 years or older. - 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 under the age of 18. - 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.
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Bayer Clinical Trials Contact [email protected]
Listed Location Countries	United Kingdom

Administrative Information

NCT Number:	NCT02850263
Other Study ID Numbers	18058
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	Bayer
Collaborators	Not Available
Investigators	Study Director Bayer Study Director Bayer