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

Bayer750 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

750

Conditions

Macular Edema

Interventions

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.

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Multiple Locations, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Baseline and 12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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