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

ID: NCT02850263
Status: Recruiting
Phase: N/A
Start Date: July 05, 2016
First Submitted: May 19, 2016
Last Updated: February 12, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: United Kingdom
Conditions: Macular Edema
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Study Description

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 Description

Condition or disease Intervention/treatment Phase

Macular Edema

Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Other Names
Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Other Names
Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Other Names
N/A

Tracking Information

First Submitted DateMay 19, 2016
Last Update Posted DateFebruary 12, 2018
Actual Start DateJuly 05, 2016
Anticipated Completion DateDecember 30, 2019
Actual Primary Completion DateDecember 30, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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]

  • 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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 Measures

Not Available

Study Design

Brief TitleA Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema
Official TitleAn Observational Study to Assess the Effectiveness of Intravitreal Aflibercept in Routine Clinical Practice tn Patients With Visual Impairment Due to Diabetic Macular Oedema (DMO)
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 Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
750
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Macular Edema
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationFemale 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.
Intervention
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.

Other Names
Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)

Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.

Other Names
Drug: Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)

Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.

Other Names
Study Groups/Cohorts
Cohort 1 / Anti-VEGF treatment naïve patients
Anti-VEGF treatment of naïve patients (who have not received any previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the United Kingdom.

Cohort 2 / Anti-VEGF treatment non-naïve patients
Anti-VEGF treatment of non-naïve patients (who have received previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.

Cohort 3 / Total study population
Anti-VEGF treatment naïve patients and anti-VEGF treatment non-naïve patients with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.

Study Arms
Cohort 1 / Anti-VEGF treatment naïve patients
Anti-VEGF treatment of naïve patients (who have not received any previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the United Kingdom.
Drug : Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.

Cohort 2 / Anti-VEGF treatment non-naïve patients
Anti-VEGF treatment of non-naïve patients (who have received previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.
Drug : Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.

Cohort 3 / Total study population
Anti-VEGF treatment naïve patients and anti-VEGF treatment non-naïve patients with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.
Drug : Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.

Arm Intervention/Treatment
Cohort 1 / Anti-VEGF treatment naïve patients
Anti-VEGF treatment of naïve patients (who have not received any previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the United Kingdom.
Drug : Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Cohort 2 / Anti-VEGF treatment non-naïve patients
Anti-VEGF treatment of non-naïve patients (who have received previous anti-VEGF treatment) with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.
Drug : Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
Cohort 3 / Total study population
Anti-VEGF treatment naïve patients and anti-VEGF treatment non-naïve patients with visual impairment due to diabetic macular oedema (DMO) in routine clinical practice in the UK.
Drug : Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)

Recruitment Information

Recruitment Status:Recruiting
Enrollment750
Completion DateDecember 30, 2019
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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United Kingdom

Administrative Information

NCT Number:NCT02850263
Other Study ID Numbers
18058
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer