NCT02850263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 5, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

2.9 years

First QC Date

May 19, 2016

Last Update Submit

November 1, 2021

Conditions

Macular Edema

Keywords

Diabetic RetinopathyDiabetic Macular OedemaDiabetic Macular EdemaAflibercept

Outcome Measures

Primary Outcomes (2)

  • Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept

    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.

    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 aflibercept

    Baseline and 12 months

Secondary Outcomes (21)

  • Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters in patients with DMO treated with intravitreal aflibercept

    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

    Baseline and 24 months

  • Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept

    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

    Baseline, 12 and 24 months

  • Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics

    Baseline, 12 and 24 months

  • +16 more secondary outcomes

Study Arms (3)

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)

Interventions

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)DRUG

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

Cohort 1 / Anti-VEGF treatment naïve patients
Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)DRUG

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 2 / Anti-VEGF treatment non-naïve patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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 must provide written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 34244670RESULT

  • Sivaprasad S, Ghanchi F, Kelly SP, Kotagiri A, Talks J, Scanlon P, McGoey H, Nolan A, Saddiq M, Napier J. Evaluation of care with intravitreal aflibercept treatment for UK patients with diabetic macular oedema: DRAKO study 24-month real-world outcomes. Eye (Lond). 2023 Sep;37(13):2753-2760. doi: 10.1038/s41433-023-02409-y. Epub 2023 Mar 20.

    PMID: 36941402DERIVED

Related Links

MeSH Terms

Conditions

Macular EdemaDiabetic Retinopathy

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

July 29, 2016

Study Start

July 5, 2016

Primary Completion

May 30, 2019

Study Completion

November 23, 2020

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Locations

GB(1)