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

Bayer

Status: Completed

Conditions: Macular Edema

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02850263

18058

Details and patient eligibility

About

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.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

750 participants in 3 patient groups

Cohort 1 / Anti-VEGF treatment naïve patients

Description:

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.

Treatment:

Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Cohort 2 / Anti-VEGF treatment non-naïve patients

Description:

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.

Treatment:

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)

Cohort 3 / Total study population

Description:

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.

Treatment:

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)