Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema

Completed

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

• Registration Number: NCT02924311
• Lead Sponsor: Bayer

Brief Summary

The main objectives of this observational study were to describe outcomes, monitoring and treatment patterns of patients with diabetic macular edema in routine clinical practice who are either treatment naïve patients or previously treated patients. The total study population was evaluated as well as the two subgroups (previously treated patients and treatment naïve patients).

This study was designated to answer French Health Authority (HAS Haute Autorité de Santé) requirements.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-05
• Study Start: 2016-09-21
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Primary Completion: 2019-08-12
• Study Completion: 2019-12-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

• Man or woman aged 18 years or older
• Patient diagnosed with a visual impairment due to diabetic macular disease (as defined by HAS (Haute Autorité de Santé) recommendation).
• Patients in whom a decision to treat with intravitreal aflibercept has been made independently of the patient enrollment in the study
• Patient diagnosed with type 1 or 2 diabetes mellitus
• Patient who has been given appropriate information about the study and who has given his/her written, informed consent

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Exclusion Criteria

• Patient with other retinal disease at the time of inclusion
• Patients currently being treated with intravitreal aflibercept. This study will only include patients new to intravitreal aflibercept
• Systemic use of any anti / pro VEGF therapy (VEGF: Vascular Endothelial Growth Factor)
• Patient taking part in an interventional study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Previously treated patient	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Already treated with any other treatment such as an anti-VEGF agent (other than IVT aflibercept), macular laser photocoagulation (laser), intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept
Naïve patient	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Not previously treated with an anti-VEGF agent, macular laser photocoagulation (laser) or intravitreal steroid injection or implant (steroids) and initiating treatment with IVT aflibercept
Entire study population	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Already treated patient with any other treatment such as an anti-VEGF agent (other than intravitreal aflibercept), macular laser photocoagulation, intravitreal steroid injection and initiating treatment with intravitreal aflibercept and not previously treated patients with an anti-VEGF agent, macular laser photocoagulation or intravitreal steroids injection and initiating treatment with intravitreal aflibercept

Primary Outcome Measures

Name	Time	Method
Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients	At baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population	At baseline and 12 months
Reason for starting intravitreal aflibercept	At baseline, 12 months and 24 months	i.e: clinically significant macular edema conducting to a decrease of visual acuity, early care of DME, laser photocoagulation or vitrectomy not indicated, diabetes care not optimized
Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups	At baseline and 24 months
Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups	At baseline and 24 months
Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-up	At baseline, 12 months and 24 months
Date of the last administered treatment in previously treated patients	At baseline
Number of eyes injected	Up to 24 months
Number of visits with injection	Up to 24 months
Mean change in blood pressure during macular disease monitoring	At baseline, 12 months and 24 months
Duration of the disease (DME Monitoring)	At baseline
Number of participants with ocular and non-ocular safety events	Up to 24 months
Number of monitoring visits for diabetes (by diabetologists, general practitioners) outside the study center over 12 and 24 months (if known by the ophthalmologist) (DME monitoring)	Up to 24 months	Monitoring visits for diabetes by diabetologists or general practitioners outside the study center
Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups	At baseline and 24 months
Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups	At baseline and 12 months
Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups	At baseline and 24 months
Type of the previous treatment(s) in previously treated patients	At baseline	i.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroids
Duration (months) of the previous treatment in previously treated patients	At baseline
Interval (days) between injections	Up to 24 months
Type of adjunctive therapy post IVT aflibercept initiation	Up to 24 months	i.e: surgery, focal laser, steroids, etc
Mean change in HbA1c level during macular disease monitoring	At baseline, 12 months and 24 months	HbA1c: Glycated haemoglobin A1c
Number of visits for monitoring only (DME Monitoring)	Up to 24 months
Number of visits with OCT assessments (DME monitoring)	Up to 24 months
Number of visits with fluorescein angiography assessments (DME monitoring)	Up to 24 months
Number of visits with visual acuity measurements (DME monitoring)	Up to 24 months
Number of visits for injection only (DME Monitoring)	Up to 24 months
Number of visits combining monitoring and injection (DME Monitoring)	Up to 24 months
Number of visits with fundus photography assessments (DME monitoring)	Up to 24 months