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

Study Overview
=================
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.

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)

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
* Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
* Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 / Anti-VEGF treatment naïve patients<br>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)<br>* Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.<br>|
| Cohort 2 / Anti-VEGF treatment non-naïve patients<br>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)<br>* 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.<br>|
| Cohort 3 / Total study population<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Retinopathy, Diabetic Macular Oedema, Diabetic Macular Edema, Aflibercept