ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613001020774

Ethics application status

Approved

Date submitted

6/09/2013

Date registered

13/09/2013

Date last updated

13/09/2013

Type of registration

Prospectively registered

Titles & IDs

Public title

To investigate the role of Intravitreal Aflibercept (Eylea) in the treatment of patients whose wet Age related Macular degeneration is not adequately controlled with conventional anti VEGF (intravitreal Avastin or Lucentis) treatment.

Scientific title

Intravitreal aflibercept for the treatment of previously treated exudative age related macular degeneration

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1140-9022

Trial acronym

AAA Study

Linked study record

Health condition

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

Exudative (Wet) Age related Macular Degeneration

Condition category

Condition code

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The trial will study the effectiveness of intravireal AFLIBERCEPT in the treatment of exudative wet Macular degeneration which thus far has not responded to other anti VEGF agents (Bevacizumab and Ranibizumab).

The dose of aflibercept administered is 2 mg. The drug will delivered by intravitreal injection every 4 weeks for the first 12 weeks of the study. Thereafter the drug will be administered by intravitreal injection every 8 weeks until the close of the trial at week 52. The duration of the study is 12 months.

For the dutration of the study, participants will attend for review every 4 weeks but they will only require treatment every second visit. During each visit the patients response to treatment will be assessed with OCT (to measure the macula thickness) and their visual acuity will be assessed.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

The patients previous lack of response to their existing anti VEGF treatment will be used as the comparitor in this trial.

This historical data will be derived from the fact that all participants in the trial will have had persiting subretinal fluid or cystic intraretinal oedema on OCT after treatment despite timely treatment with at least 4 anti-VEGF treatments delivered within minimum of 6 months. Thus all patients will have disease that has been non responsive to the conventional antiVEGF treatments for at least 6 months prior to entering the trial.

Control group

Historical

Outcomes

Primary outcome [1]

Improvement in Best Corrected Visual Acuity (as measured with the EDTRS visual acuity chart) after 12 months of treatment with intravitreal Aflibercept compared with baseline.

Timepoint [1]

12 months

Secondary outcome [1]

Anatomical resolution of subretinal fluid as measured with OCT at 12 months compared with baseline.

Timepoint [1]

12 months

Secondary outcome [2]

Improved level of well being as measured using the Impact of Visual Impairment questionnaire

Timepoint [2]

12 months

Secondary outcome [3]

Anatomical resolution of intraretinal oedema as measured with OCT at 12 months compared with baseline.

Timepoint [3]

12 months

Secondary outcome [4]

Anatomical resolution of any associated Pigment epithelial detachment as measured with OCT at 12 months compared with baseline.

Timepoint [4]

12 months

Eligibility

Key inclusion criteria

1. Ability to provide informed consent and complete study assessments
2. Age 50 years or older
3. CNV secondary to AMD
4. Best corrected baseline visual acuity between 6/6 to 6/60 on ETDRS chart
5. Presence of subretinal fluid or cystic intraretinal oedema on spectral domain OCT (SD-OCT) [Spectralis] after at least four anti-VEGF treatments within minimum of 6 months and maximum of 5 years before enrollment of the study.
6. Documentation of the presence of subretinal fluid or cystoid oedema less than 42 days since last treatment with an antiVegf agent.

Minimum age

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Pregnancy or lactation
2. Premenopausal women not using contraception
3. Prior anti-VEGF injection in the study eye within 30 days of baseline
4. Prior treatment with photo dynamic therapy (PDT) within 90 days of baseline and more than 6 prior PDT treatments
5. Significant subretinal fibrosis or atrophy
6. Prior treatment with triamcinolone in the study eye within six months of baseline
7. Intraocular surgery in the study eye within 2 months of baseline
8. Prior vitrectomy or other surgical intervention for AMD in the study eye

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)

All patients whose wet Macular Degeneration is being treated in our unit and whose disease is not responding to their existing therapies will be invited to enroll in the study. All patients enrolled into the study will receive treatment with the study drug.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

This is a non randomised study

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 3 / Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

The proportion of those patients whose visual acuity improved after 12 months will be compared to Base line. A similar analysis will be conducted to assess the proportion of patients whose disease activity (as measured by improved sub retinal fluid intra retinal oedema and Pigment epithelial detachment) improved compared to baseline.

Re sample size:
From our local audit data we found that approximately 8-10% of patients with wet AMD did not respond to conventional antiVEGF agents. We look after a total cohort of 700 patients and thus judged that approximately 70 patients were therefore being inadequately treated with the existing treatments. We also know from anecodotal data; (data which has now been supported by published trial data from small cohort studies) that many of these patients do respond to Aflibercept. As this study is an investigator lead trial we took a proposal to the drug company who are supplying the drug to conduct a trial which would allow most of our patients access to this drug. This approach would ensure that we had as large a sample size as practically possible and at the same time allow as many patietns as possible to get access to the new treatment.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/10/2013

Actual

Date of last participant enrolment

Anticipated

25/12/2013

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Auckland District Health Board

Address [1]

Department of Ophthalmology,
Greenlane Clinical Centre,
Private bag 92189
Auckland Mail centre,
Auckland 1142

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Greenlane Clinical Centre Auckland District Health Board

Address

Department of Ophthalmology,
Greenlane Clinical Centre,
Private bag 92189
Auckland Mail centre,
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Bayer New Zealand

Address [1]

Bayer New Zealand,
Bayer Healthcare Pharmaceuticals
3 Argus Place, Hillcrest,
Auckland , 0627,
New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDEC Ethics

Ethics committee address [1]

Health and Disability Ethics Committe,
Ministry of Health,
1 The Terrace,
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

15/07/2013

Ethics approval number [1]

13/NTB/66

Summary

Brief summary

The aim of the study is to evaluate the effectiveness of intravitreal Aflibercept in the treatment of  previously treated choroidal neovascularisation (CNV) secondary to age-related macular degeneration MD). 

This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug (ranibizumab or bevacizumab) for AMD and have persisting disease activity despite previous monthly intravitreal injections. All subjects will initially receive 3 monthly doses of 2.0mg of intravitreal Aflibercept injection and then have 2.0mg of intravitreal Aflibercept at two monthly intervals for the next 9 months. 
At the close of the trial the effectiveness of Aflibercept in the mangement of wet age related macular degeneration that has not responded to our existing therapies will be assessed.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Squirrell

Address

Department of Ophthalmology,
Greenlane Clinical Centre,
Private bag 92189
Auckland Mail Centre,
Auckland 1142

Country

New Zealand

Phone

+ 64 9 3074949 ext 27624

Fax

dsquirrell@adhb.govt.nz

Contact person for public queries

Name

David Squirrell

Address

Department of Ophthalmology,
Greenlane Clinical Centre,
Private bag 92189
Auckland Mail centre,
Auckland 1142

Country

New Zealand

Phone

+ 64 9 3074949 ext 27624

Fax

dsquirrell@adhb.govt.nz

Contact person for scientific queries

Name

David Squirrell

Address

Department of Ophthalmology,
Greenlane Clinical Centre,
Private bag 92189
Auckland Mail centre,
Auckland 1142

Country

New Zealand

Phone

+ 64 9 3074949 ext 27624

Fax

dsquirrell@adhb.govt.nz

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		International Journal of Ophthalmology and Clinica... [More Details]	364912-(Uploaded-23-07-2020-04-37-36)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Aflibercept for the Treatment of Recalcitrant Macular Degeneration: Results from a One Year Prospective Cohort Study. The Auckland Experience	2016	https://doi.org/10.23937/2378-346x/1410053

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

Trial Review

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Documents added manually

Documents added automatically