Trial Condition(s):
Macular Edema
A study to assess the effectiveness of aflibercept in routine clinical practice in patients with diabetic macular oedema (DRAKO)
Bayer Identifier:
18058
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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.
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.
Trial Summary
Enrollment Goal
750
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, United Kingdom | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
3
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.Timeframe: Baseline and 12 months
- Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal afliberceptTimeframe: Baseline and 12 months
Secondary Outcome
- Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal afliberceptTimeframe: 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 afliberceptTimeframe: Baseline and 24 months
- Change in non-refracted visual acuity in patients with DMO treated with intravitreal afliberceptTimeframe: 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 characteristicsTimeframe: Baseline, 12 and 24 months
- Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristicsTimeframe: Baseline, 12 and 24 months
- Proportion (%) of patients discontinuing intravitreal aflibercept treatmentTimeframe: Baseline, 12 and 24 months
- Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatmentTimeframe: Baseline
- The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatmentTimeframe: Baseline
- Proportion (%) of treated eyes with 5, 10 and 15 letter gain / lossTimeframe: Baseline, 12 and 24 months
- Proportion (%) of sites that adhere to their stated treatment protocolTimeframe: 12 and 24 months
- Change in QoL score measured by NEI VFQ-25Timeframe: Baseline, 12 and 24 months
- Change in macular volumeTimeframe: Baseline, 12 and 24 months
- Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) lettersTimeframe: Baseline, 12 and 24 months
- Change in non-refracted visual acuity (VA).for the fellow eyeTimeframe: Baseline, 12 and 24 months
- Number of DMO treatments required for the fellow eyeTimeframe: Baseline, 12 and 24 months
- Number of visits performed (resources) to assess the fellow eyeTimeframe: Baseline, 12 and 24 months
- Number of clinical procedures performed (resources) to assess the fellow eyeTimeframe: Baseline, 12 and 24 months
- Number of adverse events as a measure of safety and tolerabilityTimeframe: 24 months
- Reason for discontinuation of intravitreal aflibercept treatmentTimeframe: Baseline, 12 and 24 months
- Change in Central Subfield Thickness (CST) of the fellow eyeTimeframe: Baseline, 12 and 24 months
- Type of DMO treatments required for the fellow eyeTimeframe: Baseline, 12 and 24 months
Additional Information
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