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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

402 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-21

Study Completion Date

2019-12-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Previously treated patient

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

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Intervention Type DRUG

Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.

Naïve patient

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

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Intervention Type DRUG

Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.

Entire study population

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

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Intervention Type DRUG

Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.

Interventions

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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No