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Trial registered on ANZCTR


Registration number
ACTRN12618000428268
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
26/03/2018
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravitreal Aflibercept for the treatment of diabetic macular oedema
Scientific title
A Prospective, unmasked, study to assess the effectiveness of a treat and extend regimen of aflibercept, for the treatment of diabetic macular oedema, in a clinical setting
Secondary ID [1] 294092 0
Nil
Universal Trial Number (UTN)
Trial acronym
EIDME (Eylea in Diabetic Macular Edema)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 306672 0
Condition category
Condition code
Eye 305771 305771 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 306191 306191 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Only one eye will be selected as the treatment eye. If the patient has two eyes with macular oedema the most recently diagnosed eye will be selected as the study eye.
All subjects will receive 5 doses of 2.0mg intravitreal aflibercept one month (4 weeks) apart.
The injections will be administered by the patient's treating ophthalmologist.
Thereafter study visits and treatment will be determined by disease activity and the treating ophthalmologist. If no disease activity is present the intervals between treatments will increase by two weeks to a maximum of 12 weeks. If disease activity is present the treatment interval will decrease by 2 weeks (if >4 weeks) or be rescheduled to 4 weekly until disease activity is minimised.
The study, and this treatment regimen, will continue for two years from the date of enrolment with a maximum of 26 injections over the course of the study.
Intervention code [1] 300372 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304846 0
Best Corrected Visual acuity (early diabetic retinopathy study) EDTRS
Timepoint [1] 304846 0
Baseline, at each follow up visit. week 20, 1 year and 2 years [primary time point]
Primary outcome [2] 305205 0
The proportions of participants whose visual acuity has improved by 10 letters or more and 15 letters or more
Timepoint [2] 305205 0
1 year, 2 years [primary timepoint]
Secondary outcome [1] 343347 0
Changes in the retinal pigmented epithelium (central foveal thickness and volume) measured by SD-OCT
Timepoint [1] 343347 0
Baseline, at each follow up visit, week 20, 1 year and 2 years
Secondary outcome [2] 343349 0
Number of injections
Timepoint [2] 343349 0
1 year, 2 years
Secondary outcome [3] 343361 0
Any untoward medical occurrence after the participant signs the informed consent will be recorded as an adverse event.
Adverse events include: those associated with the injection procedure such as eye irritation, severe eye pain, reduction or clouding of vision, flashes of light or floaters, bloodshot eyes, Other changes in the participants health such as coughs, colds, chest infections, urinary tract infections, falls, disturbances in blood sugar control, unplanned hospitalisations will be identified through questioning the participant at each visit or between visits or as a result of participant examination or other assessments or medical reports from other health professionals.
Timepoint [3] 343361 0
Baseline, at each visit, 1 year, 2 years

Eligibility
Key inclusion criteria
• Written informed consent must be obtained prior to any study measures being performed
• Male or female participants aged 18 years and over, with type 1 or type 2 diabetes mellitus
• Female patients of childbearing potential should be counselled on potential risks and should use effective contraceptive measures during treatment and for up to three months after treatment ceases.

• Diagnosis of diabetic macular oedema (DME) with central macular involvement in study eye diagnosed by fluorescein angiography.
• Decrease in vision in the study eye as a consequence of DME
• Best corrected baseline visual acuity (BCVA) between 24 and 78 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 3 meters.
• Study eye Central retinal thickness (CRT) at least 300µm on OCT ( Heidelberg Spectralis OCT)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant or lactating women and women of reproductive age not using effective contraception.
• Systemic disease or a condition (controlled or uncontrolled) that, in the opinion of the investigator, might regress, recur or change and consequently have a potential impact (bias) on the assessment of study outcomes.
• Stroke or myocardial infarction less than 3 months prior to screening for eligibility.
• Uncontrolled blood pressure (defined as a systolic of >160mmHg or diastolic >100mmHg) at screening
• Uncontrolled diabetes, defined by HBA1c>12%
• Patients with known sensitivity to Aflibercept preparations
• Patients taking or planning to take any systemic medications known to be toxic to the lens or retina or optic nerve.
• Any active ocular or peri-ocular infection or inflammation
• Active proliferative diabetic retinopathy in study eye.
• Visually significant cataract
• Any other macular pathology in the study eye that may influence the outcomes of the study (e.g. laser burns or scars, wet Age-related macular degeneration, macular holes.)
• Uncontrolled glaucoma
• Any previous treatment with anti-angiogenic drugs in the study eye within 120 days of commencing the study.
• Any previous treatment with anti-angiogenic drugs in the fellow eye within 90 days of commencing the study.
• More than two previous macular laser photocoagulation treatments in the study eye in the past 6 months.
• Pan-retinal or macular laser photocoagulation in study eye within the 90 days of commencing the study.
• Treatment of study eye with intraocular /peri ocular corticosteroids within 120 days of commencing the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We calculate that the sample size required, to observe a difference of 10 letters with 80% power, would be 16 participants. The 50 participants that we intend to recruit would allow for 10% drop out over the 2 year period.
The analysis will include descriptive statistics such the number, mean, standard deviations, median and range and confidence intervals for continuous variables and the frequencies and proportions of categorical variables
The presence of confounding may also be evaluated in regression models by including baseline covariates such as: the patient age, study eye visual acuity and retinal thickness.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/02/2015
Date of last participant enrolment
Anticipated
Actual
30/08/2016
Date of last data collection
Anticipated
31/08/2018
Actual
3/09/2018
Sample size
Target
50
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 21583 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 298726 0
Commercial sector/Industry
Name [1] 298726 0
Bayer Australia Limited
Country [1] 298726 0
Australia
Primary sponsor type
Individual
Name
Nitin Verma
Address
Hobart Eye Surgeons
182 Argyle Street
Hobart , TAS 7000
Country
Australia
Secondary sponsor category [1] 297903 0
None
Name [1] 297903 0
Address [1] 297903 0
Country [1] 297903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299670 0
The Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 299670 0
Ethics committee country [1] 299670 0
Australia
Date submitted for ethics approval [1] 299670 0
03/11/2014
Approval date [1] 299670 0
13/01/2015
Ethics approval number [1] 299670 0
H0014556

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2430 2430 0 0
/AnzctrAttachments/374545-150217 H14556 Application Approval Letter v3.pdf (Ethics approval)
Attachments [2] 2431 2431 0 0
/AnzctrAttachments/374545-H0014556_EIDEME_Protocol_V4_12_Dec_14.doc (Protocol)
Attachments [3] 2432 2432 0 0
/AnzctrAttachments/374545-H0014556_EIDEME_information-sheet-for-clinical-trial_V2.pdf (Participant information/consent)
Attachments [4] 2433 2433 0 0
/AnzctrAttachments/374545-H0015556_EIDEME_Health-and-medical-consent-form.pdf (Participant information/consent)

Contacts
Principal investigator
Name 81238 0
Dr Nitin Verma
Address 81238 0
Hobart Eye Surgeons, 182 Argyle Street, Hobart. Tasmania. 7000
Country 81238 0
Australia
Phone 81238 0
+61 3 6210 6000
Fax 81238 0
+61 3 6210 6099
Email 81238 0
nitin.verma@eyesurgeons.com.au
Contact person for public queries
Name 81239 0
Beverley Curry
Address 81239 0
Hobart Eye Surgeons, 182 Argyle Street, Hobart. Tasmania. 7000
Country 81239 0
Australia
Phone 81239 0
+61 3 6210 6007
Fax 81239 0
+61 3 6210 6099
Email 81239 0
beverley.curry@eyesurgeons.com.au
Contact person for scientific queries
Name 81240 0
Nitin Verma
Address 81240 0
Hobart Eye Surgeons, 182 Argyle Street, Hobart. Tasmania. 7000
Country 81240 0
Australia
Phone 81240 0
+61 3 6210 6000
Fax 81240 0
+61 3 6210 6099
Email 81240 0
nitin.verma@eyesurgeons.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No is selected at present. The participant information provided to participants did not include the provision for sharing their data with others.
The study report and additional documentation will be provided when the study is published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClinical Outcomes of a Treat and Extend Regimen with Intravitreal Aflibercept Injections in Patients with Diabetic Macular Edema: Experience in Clinical Practice.2020https://dx.doi.org/10.1007/s40123-019-00224-x
N.B. These documents automatically identified may not have been verified by the study sponsor.