Clinical trial NCT02850263: A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema
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 (DMO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Keywords: Diabetic Retinopathy
Diabetic Macular Oedema
Diabetic Macular Edema
Aflibercept
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients with a diagnosis of diabetic macular oedema with central involvement will be enrolled after the decision for treatment with intravitreal aflibercept has been made.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept
timeFrame: Baseline and 12 months
measure: Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept
timeFrame: Baseline and 24 months
measure: Change in central subfield thickness (CST) as determined by Spectral Domain Optical Coherence Tomography (SD-OCT) in patients with DMO treated with intravitreal aflibercept
timeFrame: Baseline and 24 months
measure: Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept
timeFrame: Baseline, 12 and 24 months
measure: 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
timeFrame: Baseline, 12 and 24 months
measure: Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics
timeFrame: Baseline, 12 and 24 months
measure: Proportion (%) of patients discontinuing intravitreal aflibercept treatment
timeFrame: Baseline, 12 and 24 months
measure: Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment
timeFrame: Baseline
measure: The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment
timeFrame: Baseline
measure: Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss
timeFrame: Baseline, 12 and 24 months
measure: Proportion (%) of sites that adhere to their stated treatment protocol
timeFrame: 12 and 24 months
measure: Change in QoL score measured by NEI VFQ-25
timeFrame: Baseline, 12 and 24 months
measure: Change in macular volume
timeFrame: Baseline, 12 and 24 months
measure: Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters
timeFrame: Baseline, 12 and 24 months
measure: Change in non-refracted visual acuity (VA).for the fellow eye
timeFrame: Baseline, 12 and 24 months
measure: Number of DMO treatments required for the fellow eye
timeFrame: Baseline, 12 and 24 months
measure: Number of visits performed (resources) to assess the fellow eye
timeFrame: Baseline, 12 and 24 months
measure: Number of clinical procedures performed (resources) to assess the fellow eye
timeFrame: Baseline, 12 and 24 months
measure: Number of adverse events as a measure of safety and tolerability
timeFrame: 24 months
measure: Reason for discontinuation of intravitreal aflibercept treatment
timeFrame: Baseline, 12 and 24 months
measure: Change in Central Subfield Thickness (CST) of the fellow eye
timeFrame: Baseline, 12 and 24 months
measure: Type of DMO treatments required for the fellow eye
timeFrame: Baseline, 12 and 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Sivaprasad S, Ghanchi F, Kelly SP, Kotagiri A, Talks J, Scanlon P, McGoey H, Nolan A, Saddiq M, Napier J; DRAKO study group. Evaluation of standard of care intravitreal aflibercept treatment of diabetic macular oedema treatment-naive patients in the UK: DRAKO study 12-month outcomes. Eye (Lond). 2022 Jan;36(1):64-71. doi: 10.1038/s41433-021-01624-9. Epub 2021 Jul 9.