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Trial registered on ANZCTR


Registration number
ACTRN12614001307695
Ethics application status
Approved
Date submitted
6/02/2014
Date registered
15/12/2014
Date last updated
19/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravitreal Aflibercept for the Treatment of Treatment Resistant Diabetic Macular Oedema
Scientific title
A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of treatment resistant diabetic macular oedema
Secondary ID [1] 284039 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Oedema 291093 0
Condition category
Condition code
Eye 291437 291437 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects will initially receive 5 monthly doses of 2.0mg of intravitreal aflibercept injections and then have 2.0mg of intravitreal aflibercept at two monthly intervals for the subsequent 7 months.
Intervention code [1] 288732 0
Treatment: Drugs
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291421 0
No increase in macular thickness on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 24
Timepoint [1] 291421 0
Baseline and week 24
Secondary outcome [1] 306732 0
Best corrected (early treatment in diabetic retinopathy study) ETDRS visual acuity
Timepoint [1] 306732 0
Monthly over a 12 month period
Secondary outcome [2] 306733 0
Central foveal thickness (Retinal Pigment Epithelium to Innre Limiting Membrane) measured by SD-OCT
Timepoint [2] 306733 0
Monthly over a 12 month period
Secondary outcome [3] 306734 0
Leakage on fluorescein angiography
Timepoint [3] 306734 0
Baseline, week 24 and week 48
Secondary outcome [4] 306735 0
Peripheral capillary closure measured by standard 7-field color fundus photography, wild-field tomography (HRT3 and Optos)
Timepoint [4] 306735 0
Baseline, week 12, week 24, week 36 and week 48
Secondary outcome [5] 306736 0
Retinal function assessed with Macular Integrity Assessment (MAIA)
Timepoint [5] 306736 0
Baseline, week 24 and week 48
Secondary outcome [6] 306737 0
Health Related Quality of Life by NEI VFQ-25, EQ-5DY and IVI questionnaires
Timepoint [6] 306737 0
Baseline, week 24 and week 48 for NEI VFQ-25 and IVI.
Monthly for EQ-5DY

Eligibility
Key inclusion criteria
*Ability to provide informed consent and complete study assessments
*Age 18 years or older
*Macular oedema involving in central macula secondary to type 1 or type 2 diabetic mellitus in study eye.
*Best corrected baseline visual acuity between 85-34 letters on early treatment in diabetic retinopathy study (ETDRS) chart (Snellen equivalent 6/6 to 6/60) on study eye
*Presence of central diabetic macular odema (DMO) >300 microns on spectral domain optical coherence tomography (SD-OCT) after at least 4 anti-VEGF (vascular endothelial growth factor) treatments within minimum of 6 months
*Documentation of the presence of macular oedema at least 30 days since last treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Pregnancy or lactation
*Premenopausal women not using contraception
*Prior anti-VEGF injection in the study eye within 30 days of baseline
*Prior treatment with triamcinolone in the study eye within 3 months of baseline
*Intraocular surgery in the study eye within 2 months of baseline
*Macular laser within 2 months or previous laser scar would prevent the improvement of macular function
*Prior vitrectomy in the study eye within 3 months of baseline
*Current vitreous haemorrhage or inflammation in the study eye
*Uncontrolled glaucoma in the study eye. Intraocular pressure (IOP) greater than 30mmHg on maximal medical therapy.
*Active proliferative diabetic retinopathy (PDR) in the study eye.
*Ischemic maculopathy on fluorescein angiography defined as a total area of capillary loss greater than 2 disc areas (> 5mm2) within the ETDRS macular grid or a foveal avascular zone greatest linear diameter of > 1000 microns
*Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion)
*Macular oedema due to other causes including vitreous traction
*An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy)
*Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
*Severe media opacity
*History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment
*Allergy to fluorescein dye.
*Uncontrolled high blood pressure (blood pressure > 180/110 mmHg)

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)
Patients diagnosed with persistent diabetic macualr oedema who have been previously treated with intravitreal anti-VEGF therapy with a minimum of 4 consecutive injections within 6 months, will be invited to participate at Sydney Retina Clnic and Day Surgery, Australia. All subjects will receive 2.0mg intravitreal aflibercept
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised trial
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
Efficacy
Statistical methods / analysis
A power calculation has been performed on 50 participants. When mean change in visual acuity in the population is estimated to be 55 letters, with a 20% standard deviation and a 5% significance, the power to detect a change of 5 letters is 88%. When the mean central macular thickness is estimated to be 400 microns, with a 20% standard deviation and a 5% significance level, the power to detect a change of 50 microns is 99%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/07/2014
Actual
6/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2053 0
Sydney Retina Clinic & Day Surgery - Sydney
Recruitment postcode(s) [1] 7744 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 288667 0
Self funded/Unfunded
Name [1] 288667 0
Andrew Chang, primary investigator
Country [1] 288667 0
Australia
Primary sponsor type
Individual
Name
Andrew Chang
Address
Sydney Retina Clinic & Day Surgery, Level 13 Park House, 197 Macquarie Street Sydney 2000, NSW, Australia, primary investigator
Country
Australia
Secondary sponsor category [1] 287375 0
None
Name [1] 287375 0
Address [1] 287375 0
Country [1] 287375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290517 0
Bellberry
Ethics committee address [1] 290517 0
Ethics committee country [1] 290517 0
Australia
Date submitted for ethics approval [1] 290517 0
07/02/2014
Approval date [1] 290517 0
02/07/2014
Ethics approval number [1] 290517 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46054 0
Dr Andrew Chang
Address 46054 0
Level 13 Park House, 187 Macquarie Street Sydney 2000, NSW,

Sydney Institute of Vision Science
Country 46054 0
Australia
Phone 46054 0
+612 9221 3755
Fax 46054 0
+612 9221 1637
Email 46054 0
achang@sydneyretina.com.au
Contact person for public queries
Name 46055 0
Thomas Hong
Address 46055 0
Level 13 Park House, 187 Macquarie Street Sydney 2000, NSW


Sydney Institute of Vision Science
Country 46055 0
Australia
Phone 46055 0
+612 9221 3755
Fax 46055 0
+612 9221 1637
Email 46055 0
thong@sydneyretina.com.au
Contact person for scientific queries
Name 46056 0
Andrew Chang
Address 46056 0
Level 13 Park House, 187 Macquarie Street Sydney 2000, NSW

Sydney Institute of Vision Science
Country 46056 0
Australia
Phone 46056 0
+612 9221 3755
Fax 46056 0
+612 9221 1637
Email 46056 0
achang@sydneyretina.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes AFLIBERCEPT FOR PERSISTENT DIABETIC MACULAR EDEMA ... [More Details] 365749-(Uploaded-19-11-2020-09-04-55)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSwitching therapy from bevacizumab to aflibercept for the management of persistent diabetic macular edema.2017https://dx.doi.org/10.1007/s00417-017-3624-y
EmbaseAFLIBERCEPT for PERSISTENT DIABETIC MACULAR EDEMA: Forty-Eight-Week Outcomes.2019https://dx.doi.org/10.1097/IAE.0000000000002253
EmbaseUltra-widefield fluorescein angiography as a biomarker for response to switch in therapy in persistent DME.2019https://dx.doi.org/10.3928/23258160-20191119-04
N.B. These documents automatically identified may not have been verified by the study sponsor.