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

Diabetic Retinopathy Clinical Trial

— APOLLON  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924311
• Other study ID #: 18636
• Status: Completed
• Start date: September 21, 2016
• Est. completion date: December 6, 2019

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: December 6, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Edema

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

France, 

References & Publications (1)

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 ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of prior treatments (DME Monitoring)		Up to 24 months
Other	Number of patients with prior photocoagulation laser therapy (DME Monitoring)		Up to 24 months
Other	Number of patients with prior anti-VEGF treatment (DME Monitoring)		Up to 24 months
Other	Number of patients with prior intraocular steroids (DME Monitoring)		Up to 24 months
Primary	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	Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population		At baseline and 12 months
Secondary	Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups		At baseline and 24 months
Secondary	Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups		At baseline and 12 months
Secondary	Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups		At baseline and 24 months
Secondary	Type of the previous treatment(s) in previously treated patients	i.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroids	At baseline
Secondary	Duration (months) of the previous treatment in previously treated patients		At baseline
Secondary	Date of the last administered treatment in previously treated patients		At baseline
Secondary	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
Secondary	Number of eyes injected		Up to 24 months
Secondary	Number of visits with injection		Up to 24 months
Secondary	Interval (days) between injections		Up to 24 months
Secondary	Type of adjunctive therapy post IVT aflibercept initiation	i.e: surgery, focal laser, steroids, etc	Up to 24 months
Secondary	Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups		At baseline and 24 months
Secondary	Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups		At baseline and 24 months
Secondary	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
Secondary	Mean change in HbA1c level during macular disease monitoring	HbA1c: Glycated haemoglobin A1c	At baseline, 12 months and 24 months
Secondary	Mean change in blood pressure during macular disease monitoring		At baseline, 12 months and 24 months
Secondary	Duration of the disease (DME Monitoring)		At baseline
Secondary	Number of visits for monitoring only (DME Monitoring)		Up to 24 months
Secondary	Number of visits for injection only (DME Monitoring)		Up to 24 months
Secondary	Number of visits combining monitoring and injection (DME Monitoring)		Up to 24 months
Secondary	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
Secondary	Number of visits with OCT assessments (DME monitoring)		Up to 24 months
Secondary	Number of visits with fundus photography assessments (DME monitoring)		Up to 24 months
Secondary	Number of visits with fluorescein angiography assessments (DME monitoring)		Up to 24 months
Secondary	Number of visits with visual acuity measurements (DME monitoring)		Up to 24 months
Secondary	Number of participants with ocular and non-ocular safety events		Up to 24 months

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