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

Completed

• Conditions: Macular Edema
• Interventions: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT02850263
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-19
• Study Start: 2016-07-05
• Study First Submitted QC: 2016-07-27
• Study First Posted: 2016-07-29
• Primary Completion: 2019-05-30
• Study Completion: 2020-11-23
• Status Verified: 2021-10
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1 / Anti-VEGF treatment naïve patients	Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)	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.

Primary Outcome Measures

Name	Time	Method
Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept	Baseline and 12 months	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.
Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Change in macular volume	Baseline, 12 and 24 months
Proportion (%) of sites that adhere to their stated treatment protocol	12 and 24 months
Change in QoL score measured by NEI VFQ-25	Baseline, 12 and 24 months
Number of visits performed (resources) to assess the fellow eye	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	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	Baseline and 24 months
Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept	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	Baseline, 12 and 24 months
Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics	Baseline, 12 and 24 months
Proportion (%) of patients discontinuing intravitreal aflibercept treatment	Baseline, 12 and 24 months
Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment	Baseline
The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment	Baseline
Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss	Baseline, 12 and 24 months
Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters	Baseline, 12 and 24 months
Change in non-refracted visual acuity (VA).for the fellow eye	Baseline, 12 and 24 months
Number of DMO treatments required for the fellow eye	Baseline, 12 and 24 months
Number of clinical procedures performed (resources) to assess the fellow eye	Baseline, 12 and 24 months
Number of adverse events as a measure of safety and tolerability	24 months
Reason for discontinuation of intravitreal aflibercept treatment	Baseline, 12 and 24 months
Change in Central Subfield Thickness (CST) of the fellow eye	Baseline, 12 and 24 months
Type of DMO treatments required for the fellow eye	Baseline, 12 and 24 months