ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetic Macular Oedema

Condition category

Condition code

Eye

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]

Treatment: Drugs

Comparator / control treatment

No control treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

No increase in macular thickness on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 24

Timepoint [1]

Baseline and week 24

Secondary outcome [1]

Best corrected (early treatment in diabetic retinopathy study) ETDRS visual acuity

Timepoint [1]

Monthly over a 12 month period

Secondary outcome [2]

Central foveal thickness (Retinal Pigment Epithelium to Innre Limiting Membrane) measured by SD-OCT

Timepoint [2]

Monthly over a 12 month period

Secondary outcome [3]

Leakage on fluorescein angiography

Timepoint [3]

Baseline, week 24 and week 48

Secondary outcome [4]

Peripheral capillary closure measured by standard 7-field color fundus photography, wild-field tomography (HRT3 and Optos)

Timepoint [4]

Baseline, week 12, week 24, week 36 and week 48

Secondary outcome [5]

Retinal function assessed with Macular Integrity Assessment (MAIA)

Timepoint [5]

Baseline, week 24 and week 48

Secondary outcome [6]

Health Related Quality of Life by NEI VFQ-25, EQ-5DY and IVI questionnaires

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Sydney Retina Clinic & Day Surgery - Sydney

Recruitment postcode(s) [1]

2000 - Sydney

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Andrew Chang, primary investigator

Address [1]

Level 13 Park House, 197 Macquarie Street Sydney 2000, NSW, Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry

Ethics committee address [1]

129 Glen Osmond Road Eastwood South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/02/2014

Approval date [1]

02/07/2014

Ethics approval number [1]

Summary

Brief summary

This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for DMO and have persisting DMO despite regular injections. The study will describe the effectiveness, safety of intravitreal aflibercept and changes in health-related quality of life (HRQoL) among these patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Andrew Chang

Address

Level 13 Park House, 187 Macquarie Street Sydney 2000, NSW,

Sydney Institute of Vision Science

Country

Australia

Phone

+612 9221 3755

Fax

+612 9221 1637

[email protected]

Contact person for public queries

Name

Thomas Hong

Address

Level 13 Park House, 187 Macquarie Street Sydney 2000, NSW

Sydney Institute of Vision Science

Country

Australia

Phone

+612 9221 3755

Fax

+612 9221 1637

[email protected]

Contact person for scientific queries

Name

Andrew Chang

Address

Level 13 Park House, 187 Macquarie Street Sydney 2000, NSW

Sydney Institute of Vision Science

Country

Australia

Phone

+612 9221 3755

Fax

+612 9221 1637

[email protected]

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		AFLIBERCEPT FOR PERSISTENT DIABETIC MACULAR EDEMA ... [More Details]	365749-(Uploaded-19-11-2020-09-04-55)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Switching therapy from bevacizumab to aflibercept for the management of persistent diabetic macular edema.	2017	https://dx.doi.org/10.1007/s00417-017-3624-y
Embase	AFLIBERCEPT for PERSISTENT DIABETIC MACULAR EDEMA: Forty-Eight-Week Outcomes.	2019	https://dx.doi.org/10.1097/IAE.0000000000002253
Embase	Ultra-widefield fluorescein angiography as a biomarker for response to switch in therapy in persistent DME.	2019	https://dx.doi.org/10.3928/23258160-20191119-04

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically