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Completed

NCT Number: NCT02850263

A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema

Intravitreal aflibercept has been approved for the treatment of visual impairments due to diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively.

The main objectives of this observational cohort field study are to evaluate effectiveness of intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti vascular endothelial growth factor (anti-VEGF) treatment naïve patients with DMO in routine clinical practice in the United Kingdom.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18 years or older.
  • Patients diagnosed with type 1 or 2 diabetes mellitus.
  • Patients diagnosed with DMO with central involvement (defined as the area of the centre subfield of OCT) treated with intravitreal aflibercept (in accordance with routine practice).
  • Patients for whom the decision to initiate treatment with intravitreal aflibercept was made as per the investigator's routine treatment practice and prior to study inclusion.
  • Patients must provide written informed consent.

Exclusion criteria

  • Patients under the age of 18.
  • Patients with contraindications as listed in the SmPC for intravitreal aflibercept.
  • Patients with pre-planned cataract surgery during the observational period.
  • Patients previously treated with intravitreal anti-VEGF within 28 days.
  • Patients currently or previously treated with systemic anti-VEGF.
  • Patients previously treated with intravitreal fluocinolone acetonide steroid.
  • Patients participating in an investigational programme with interventions outside of routine clinical practice.

Treatment and study plan

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

Drug

Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.

Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)

Drug

Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.

Primary outcomes

  1. Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept

    Time frame: Baseline and 12 months

    BCVA (Best Corrected Visual Acuity): process to measure with the help of a retinoscope, auto-refractor or phoropter how much power is needed to bring the eye to normal, perfectly focused vision) when performed in addition to that at baseline and 12 months. ETDRS Chart: charts imprinted with lines of letters decreasing in size from largest on top to smallest on the bottom to determine visual acuity.

  2. Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept

    Time frame: Baseline and 12 months

Secondary outcomes

  1. Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept

    Time frame: Baseline and 24 months

  2. Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept

    Time frame: Baseline and 24 months

  3. Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept

    Time frame: Baseline, 12 and 24 months

  4. Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept differentiated by BCVA baseline characteristics

    Time frame: Baseline, 12 and 24 months

  5. Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics

    Time frame: Baseline, 12 and 24 months

  6. Proportion (%) of patients discontinuing intravitreal aflibercept treatment

    Time frame: Baseline, 12 and 24 months

  7. Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment

    Time frame: Baseline

  8. The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment

    Time frame: Baseline

  9. Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss

    Time frame: Baseline, 12 and 24 months

  10. Proportion (%) of sites that adhere to their stated treatment protocol

    Time frame: 12 and 24 months

  11. Change in QoL score measured by NEI VFQ-25

    Time frame: Baseline, 12 and 24 months

  12. Change in macular volume

    Time frame: Baseline, 12 and 24 months

  13. Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters

    Time frame: Baseline, 12 and 24 months

  14. Change in non-refracted visual acuity (VA).for the fellow eye

    Time frame: Baseline, 12 and 24 months

  15. Number of DMO treatments required for the fellow eye

    Time frame: Baseline, 12 and 24 months

  16. Number of visits performed (resources) to assess the fellow eye

    Time frame: Baseline, 12 and 24 months

  17. Number of clinical procedures performed (resources) to assess the fellow eye

    Time frame: Baseline, 12 and 24 months

  18. Number of adverse events as a measure of safety and tolerability

    Time frame: 24 months

  19. Reason for discontinuation of intravitreal aflibercept treatment

    Time frame: Baseline, 12 and 24 months

  20. Change in Central Subfield Thickness (CST) of the fellow eye

    Time frame: Baseline, 12 and 24 months

  21. Type of DMO treatments required for the fellow eye

    Time frame: Baseline, 12 and 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

An Observational Study to Assess the Effectiveness of Intravitreal Aflibercept in Routine Clinical Practice tn Patients With Visual Impairment Due to Diabetic Macular Oedema (DMO)

Acronym: DRAKO

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jul 29, 2016
Registry last updated
Nov 2, 2021

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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