check_circleStudy Completed

Macular edema

Bayer Identifier:

18058

ClinicalTrials.gov Identifier:

NCT02850263

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to assess the effectiveness of aflibercept in routine clinical practice in patients with diabetic macular oedema

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.


  • - 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.

Trial summary

Enrollment Goal
750
Trial Dates
July 2016 - November 2020
Phase
N/A
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, United Kingdom

Primary Outcome

  • Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept
    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.
    date_rangeTime Frame:
    Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept
    date_rangeTime Frame:
    Baseline and 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion (%) of patients discontinuing intravitreal aflibercept treatment
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion (%) of sites that adhere to their stated treatment protocol
    date_rangeTime Frame:
    12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in QoL score measured by NEI VFQ-25
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in macular volume
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in non-refracted visual acuity (VA).for the fellow eye
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of DMO treatments required for the fellow eye
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of visits performed (resources) to assess the fellow eye
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of clinical procedures performed (resources) to assess the fellow eye
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Reason for discontinuation of intravitreal aflibercept treatment
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in Central Subfield Thickness (CST) of the fellow eye
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Type of DMO treatments required for the fellow eye
    date_rangeTime Frame:
    Baseline, 12 and 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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