Trial Condition(s):

Macular Edema

A study to assess the effectiveness of aflibercept in routine clinical practice in patients with diabetic macular oedema (DRAKO)

Bayer Identifier:

18058

ClinicalTrials.gov Identifier:

NCT02850263

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
750
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, United Kingdom

Status
Completed
 

Trial Design