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Completed

NCT Number: NCT02924311

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

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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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean change in Best Corrected Visual Acuity from baseline to month 12 in treatment naïve patients and previously treated patients

    Time frame: At baseline and 12 months

Secondary outcomes

  1. Mean change in Best Corrected Visual Acuity between baseline and 12-month follow-up for the entire study population

    Time frame: At baseline and 12 months

  2. Mean change in Best Corrected Visual Acuity between baseline and 24-month follow-up for all groups

    Time frame: At baseline and 24 months

  3. Mean change in Central Retinal Thickness between baseline and 12-month follow-up for all groups

    Time frame: At baseline and 12 months

  4. Mean change in Central Retinal Thickness between baseline visit and 24-month follow-up for all groups

    Time frame: At baseline and 24 months

  5. Type of the previous treatment(s) in previously treated patients

    Time frame: At baseline

    i.e: photocoagulation laser therapy, anti-VEGF treatment, intraocular steroids

  6. Duration (months) of the previous treatment in previously treated patients

    Time frame: At baseline

  7. Date of the last administered treatment in previously treated patients

    Time frame: At baseline

  8. Reason for starting intravitreal aflibercept

    Time frame: 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

  9. Number of eyes injected

    Time frame: Up to 24 months

  10. Number of visits with injection

    Time frame: Up to 24 months

  11. Interval (days) between injections

    Time frame: Up to 24 months

  12. Type of adjunctive therapy post IVT aflibercept initiation

    Time frame: Up to 24 months

    i.e: surgery, focal laser, steroids, etc

  13. Proportion of patients with change in fluorescein angiograph outcomes between baseline and 24-month follow-up for all groups

    Time frame: At baseline and 24 months

  14. Proportion of patients with change in fundus photography outcomes between baseline and 24-month follow-up for all groups

    Time frame: At baseline and 24 months

  15. Proportion of patients with no fluid determined by optical coherence tomography (OCT) between baseline and 24-month follow-up

    Time frame: At baseline, 12 months and 24 months

  16. Mean change in HbA1c level during macular disease monitoring

    Time frame: At baseline, 12 months and 24 months

    HbA1c: Glycated haemoglobin A1c

  17. Mean change in blood pressure during macular disease monitoring

    Time frame: At baseline, 12 months and 24 months

  18. Duration of the disease (DME Monitoring)

    Time frame: At baseline

  19. Number of visits for monitoring only (DME Monitoring)

    Time frame: Up to 24 months

  20. Number of visits for injection only (DME Monitoring)

    Time frame: Up to 24 months

  21. Number of visits combining monitoring and injection (DME Monitoring)

    Time frame: Up to 24 months

  22. 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)

    Time frame: Up to 24 months

    Monitoring visits for diabetes by diabetologists or general practitioners outside the study center

  23. Number of visits with OCT assessments (DME monitoring)

    Time frame: Up to 24 months

  24. Number of visits with fundus photography assessments (DME monitoring)

    Time frame: Up to 24 months

  25. Number of visits with fluorescein angiography assessments (DME monitoring)

    Time frame: Up to 24 months

  26. Number of visits with visual acuity measurements (DME monitoring)

    Time frame: Up to 24 months

  27. Number of participants with ocular and non-ocular safety events

    Time frame: Up to 24 months

Other outcomes

  1. Number of prior treatments (DME Monitoring)

    Time frame: Up to 24 months

  2. Number of patients with prior photocoagulation laser therapy (DME Monitoring)

    Time frame: Up to 24 months

  3. Number of patients with prior anti-VEGF treatment (DME Monitoring)

    Time frame: Up to 24 months

  4. Number of patients with prior intraocular steroids (DME Monitoring)

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: APOLLON

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2016
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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