check_circleStudy Completed
Macular edema
Bayer Identifier:
18058
ClinicalTrials.gov Identifier:
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.
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
BothAge
18 - N/ATrial summary
Enrollment Goal
750Trial Dates
July 2016 - November 2020Phase
N/ACould I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 afliberceptBCVA (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 monthsenhanced_encryptionNoSafety Issue:
- Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal afliberceptdate_rangeTime Frame:Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal afliberceptdate_rangeTime Frame:Baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal afliberceptdate_rangeTime Frame:Baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in non-refracted visual acuity in patients with DMO treated with intravitreal afliberceptdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- 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 characteristicsdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristicsdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Proportion (%) of patients discontinuing intravitreal aflibercept treatmentdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatmentdate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatmentdate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Proportion (%) of treated eyes with 5, 10 and 15 letter gain / lossdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Proportion (%) of sites that adhere to their stated treatment protocoldate_rangeTime Frame:12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in QoL score measured by NEI VFQ-25date_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in macular volumedate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) lettersdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in non-refracted visual acuity (VA).for the fellow eyedate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of DMO treatments required for the fellow eyedate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of visits performed (resources) to assess the fellow eyedate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of clinical procedures performed (resources) to assess the fellow eyedate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Number of adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:24 monthsenhanced_encryptionYesSafety Issue:
- Reason for discontinuation of intravitreal aflibercept treatmentdate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Change in Central Subfield Thickness (CST) of the fellow eyedate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
- Type of DMO treatments required for the fellow eyedate_rangeTime Frame:Baseline, 12 and 24 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A