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

Conditions

• Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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) — 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.

Study Details

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.

Key Dates

Start date

Jul 5, 2016

Status verified

Oct 2021

Primary completion

May 30, 2019

Completion

Nov 23, 2020

Study Design

Enrollment

750 participants (actual)

Arms

• Arm: Cohort 1 / Anti-VEGF treatment naïve patients
  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.
• Arm: Cohort 2 / Anti-VEGF treatment non-naïve patients
  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.
• Arm: Cohort 3 / Total study population
  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.

Primary Outcome Measure

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 12 months ]

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