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

• Status: Completed
• Trial end date: 2020-11-23
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Aflibercept; Bevacizumab

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.