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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population | At baseline and 12 months | |
| Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups | At baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of prior treatments (DME Monitoring) | Up to 24 months | |
| Number of patients with prior photocoagulation laser therapy (DME Monitoring) | Up to 24 months | |
| Number of patients with prior anti-VEGF treatment (DME Monitoring) |
Inclusion Criteria:
Exclusion Criteria:
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Treatment naïve and previously treated diabetic macular disease patients initiating a treatment with intravitreal aflibercept.
The prescription of the medicines is clearly separated from the decision to include the patient in the study
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36309572 | Result | Korobelnik JF, Daien V, Faure C, Tadayoni R, Giocanti-Auregan A, Dot C, Kodjikian L, Massin P; APOLLON study investigators. Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema. Sci Rep. 2022 Oct 29;12(1):18242. doi: 10.1038/s41598-022-22838-1. |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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|
| 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 | i.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroids | At baseline |
| Duration (months) of the previous treatment in previously treated patients | At baseline |
| Date of the last administered treatment in previously treated patients | At baseline |
| Reason for starting intravitreal aflibercept | 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 | At baseline, 12 months and 24 months |
| Number of eyes injected | Up to 24 months |
| Number of visits with injection | Up to 24 months |
| Interval (days) between injections | Up to 24 months |
| Type of adjunctive therapy post IVT aflibercept initiation | i.e: surgery, focal laser, steroids, etc | Up to 24 months |
| 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 |
| Mean change in HbA1c level during macular disease monitoring | HbA1c: Glycated haemoglobin A1c | At baseline, 12 months and 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 visits for monitoring only (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 monitoring visits for diabetes (by diabetologists, general practitioners) outside the study center over 12 and 24 months (if known by the ophthalmologist) (DME monitoring) | Monitoring visits for diabetes by diabetologists or general practitioners outside the study center | Up to 24 months |
| Number of visits with OCT assessments (DME monitoring) | Up to 24 months |
| Number of visits with fundus photography 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 participants with ocular and non-ocular safety events | Up to 24 months |
| Up to 24 months |
| Number of patients with prior intraocular steroids (DME Monitoring) | Up to 24 months |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |