Clinical trial NCT02924311: Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Official title: A Prospective Observational Study Conducted in France to Describe Routine Clinical Practice for Treatment naïve or Previously Treated Patients With Diabetic Macular Edema (DME) Who Are Starting IVT Aflibercept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Keywords: Diabetic Macular Edema
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2016-10-05
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients
timeFrame: At baseline and 12 months
Secondary outcomes:
measure: Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population
timeFrame: At baseline and 12 months
measure: Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups
timeFrame: At baseline and 24 months
measure: Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups
timeFrame: At baseline and 12 months
measure: Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups
timeFrame: At baseline and 24 months
measure: Type of the previous treatment(s) in previously treated patients
timeFrame: At baseline
measure: Duration (months) of the previous treatment in previously treated patients
timeFrame: At baseline
measure: Date of the last administered treatment in previously treated patients
timeFrame: At baseline
measure: Reason for starting intravitreal aflibercept
timeFrame: At baseline, 12 months and 24 months
measure: Number of eyes injected
timeFrame: Up to 24 months
measure: Number of visits with injection
timeFrame: Up to 24 months
measure: Interval (days) between injections
timeFrame: Up to 24 months
measure: Type of adjunctive therapy post IVT aflibercept initiation
timeFrame: Up to 24 months
measure: Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups
timeFrame: At baseline and 24 months
measure: Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups
timeFrame: At baseline and 24 months
measure: Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-up
timeFrame: At baseline, 12 months and 24 months
measure: Mean change in HbA1c level during macular disease monitoring
timeFrame: At baseline, 12 months and 24 months
measure: Mean change in blood pressure during macular disease monitoring
timeFrame: At baseline, 12 months and 24 months
measure: Duration of the disease (DME Monitoring)
timeFrame: At baseline
measure: Number of visits for monitoring only (DME Monitoring)
timeFrame: Up to 24 months
measure: Number of visits for injection only (DME Monitoring)
timeFrame: Up to 24 months
measure: Number of visits combining monitoring and injection (DME Monitoring)
timeFrame: Up to 24 months
measure: 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)
timeFrame: Up to 24 months
measure: Number of visits with OCT assessments (DME monitoring)
timeFrame: Up to 24 months
measure: Number of visits with fundus photography assessments (DME monitoring)
timeFrame: Up to 24 months
measure: Number of visits with fluorescein angiography assessments (DME monitoring)
timeFrame: Up to 24 months
measure: Number of visits with visual acuity measurements (DME monitoring)
timeFrame: Up to 24 months
measure: Number of participants with ocular and non-ocular safety events
timeFrame: Up to 24 months
Other outcomes:
measure: Number of prior treatments (DME Monitoring)
timeFrame: Up to 24 months
measure: Number of patients with prior photocoagulation laser therapy (DME Monitoring)
timeFrame: Up to 24 months
measure: Number of patients with prior anti-VEGF treatment (DME Monitoring)
timeFrame: Up to 24 months
measure: Number of patients with prior intraocular steroids (DME Monitoring)
timeFrame: Up to 24 months
Locations:
city: Multiple Locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.