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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official 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

Brief Summary:

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.


Detailed Summary:
Sponsor: Bayer

Current 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 [ 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.
  • 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 ]


Original Primary Outcome: Same as current

Current 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 [ Time Frame: Baseline and 24 months ]
  • 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 ]
  • Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept [ Time Frame: Baseline, 12 and 24 months ]
  • 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 ]
  • 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 ]
  • Proportion (%) of patients discontinuing intravitreal aflibercept treatment [ Time Frame: Baseline, 12 and 24 months ]
  • Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment [ Time Frame: Baseline ]
  • The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment [ Time Frame: Baseline ]
  • Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss [ Time Frame: Baseline, 12 and 24 months ]
  • Proportion (%) of sites that adhere to their stated treatment protocol [ Time Frame: 12 and 24 months ]
  • Change in QoL score measured by NEI VFQ-25 [ Time Frame: Baseline, 12 and 24 months ]
  • Change in macular volume [ Time Frame: Baseline, 12 and 24 months ]
  • Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters [ Time Frame: Baseline, 12 and 24 months ]
  • Change in non-refracted visual acuity (VA).for the fellow eye [ Time Frame: Baseline, 12 and 24 months ]
  • Number of DMO treatments required for the fellow eye [ Time Frame: Baseline, 12 and 24 months ]
  • Number of visits performed (resources) to assess the fellow eye [ Time Frame: Baseline, 12 and 24 months ]
  • Number of clinical procedures performed (resources) to assess the fellow eye [ Time Frame: Baseline, 12 and 24 months ]
  • Number of adverse events as a measure of safety and tolerability [ Time Frame: 24 months ]
  • Reason for discontinuation of intravitreal aflibercept treatment [ Time Frame: Baseline, 12 and 24 months ]
  • Change in Central Subfield Thickness (CST) of the fellow eye [ Time Frame: Baseline, 12 and 24 months ]
  • Type of DMO treatments required for the fellow eye [ Time Frame: Baseline, 12 and 24 months ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: May 19, 2016
Date Started: July 5, 2016
Date Completion: September 30, 2019
Last Updated: May 9, 2017
Last Verified: May 2017