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

Macular Edema Clinical Trial

— DRAKO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850263
• Other study ID #: 18058
• Status: Completed
• Start date: July 5, 2016
• Est. completion date: November 23, 2020

Study information

• Verified date: October 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: November 23, 2020
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Macular Edema

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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: D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Change in non-refracted visual acuity in patients with DMO treated with intravitreal aflibercept		Baseline, 12 and 24 months
Secondary	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
Secondary	Change in central subfield thickness (CST) in patients with DMO treated with intravitreal aflibercept differentiated by CST baseline characteristics		Baseline, 12 and 24 months
Secondary	Proportion (%) of patients discontinuing intravitreal aflibercept treatment		Baseline, 12 and 24 months
Secondary	Time between the decision to treat for patients with DMO who have not received any previous anti-VEGF treatment		Baseline
Secondary	The time between the date of DMO diagnosis for patients with DMO who have received any previous anti-VEGF treatment		Baseline
Secondary	Proportion (%) of treated eyes with 5, 10 and 15 letter gain / loss		Baseline, 12 and 24 months
Secondary	Proportion (%) of sites that adhere to their stated treatment protocol		12 and 24 months
Secondary	Change in QoL score measured by NEI VFQ-25		Baseline, 12 and 24 months
Secondary	Change in macular volume		Baseline, 12 and 24 months
Secondary	Change in Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters		Baseline, 12 and 24 months
Secondary	Change in non-refracted visual acuity (VA).for the fellow eye		Baseline, 12 and 24 months
Secondary	Number of DMO treatments required for the fellow eye		Baseline, 12 and 24 months
Secondary	Number of visits performed (resources) to assess the fellow eye		Baseline, 12 and 24 months
Secondary	Number of clinical procedures performed (resources) to assess the fellow eye		Baseline, 12 and 24 months
Secondary	Number of adverse events as a measure of safety and tolerability		24 months
Secondary	Reason for discontinuation of intravitreal aflibercept treatment		Baseline, 12 and 24 months
Secondary	Change in Central Subfield Thickness (CST) of the fellow eye		Baseline, 12 and 24 months
Secondary	Type of DMO treatments required for the fellow eye		Baseline, 12 and 24 months

External Links

•   Click here to find results for studies related to Bayer products