Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000666820
Ethics application status
Approved
Date submitted
19/06/2012
Date registered
21/06/2012
Date last updated
16/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneration
Scientific title
A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of previously treated exudative age-related macular degeneration
Secondary ID [1] 280692 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exudative age-related macular degeneration 286720 0
Condition category
Condition code
Eye 287021 287021 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will initially receive 2.0mg Aflibercept intravitreal injections every month for 3 months and then every two months for the next 9 months. The overall duration of this treatment is 1 year.
Intervention code [1] 285103 0
Treatment: Drugs
Comparator / control treatment
No Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287360 0
No increase in macular thickness or fluid on optical coherence tomography.

No reduction of best corrected ETDRS visual acuity of more than 5 letters
Timepoint [1] 287360 0
Baseline and Week 24
Secondary outcome [1] 297987 0
Best corrected visual acuity will be tested by Early Treatment Diabetic Retinopathy Study (ETDRS) eye Charts. The patients will be asked to read letters from the top of the chart to the bottom, and the visual acuity is scored by how many letters could be correctly identified.
Timepoint [1] 297987 0
Baseline, Week 12, week 24, and Week 48
Secondary outcome [2] 297988 0
Central and inner macular thickness (from retinal pigment epithelium to inner limiting membrane) measured by optical coherence tomography
Timepoint [2] 297988 0
Baseline, Week 12, week 24, and Week 48
Secondary outcome [3] 297989 0
The leakage area of the fluorescein dye form retinal or choroidal vessels on fluorescein angiography
Timepoint [3] 297989 0
Baseline, week 24 and Week 48
Secondary outcome [4] 297990 0
Central visual field (Macular function ) is assessed by Flicker Frequency Perimetry (Medmont)
Timepoint [4] 297990 0
Baseline, week 24 and Week 48
Secondary outcome [5] 297991 0
Health-related quality of life assessed by National Eye Institute Visual Functioning Questionnaire-25
Timepoint [5] 297991 0
Baseline, Week 24 and Week 48

Eligibility
Key inclusion criteria
1. Ability to provide informed consent and complying with the study assessments who are the
2. Age 50 years or older
3. Choroidal neovascularization secondary to age-realted macular degeneration
4. Best corrected vision between 6/6 to 6/60 on EDTRS chart
5. Presence of subretinal fluid or cystic intraretinal oedema on optical coherence tomography after at least 4 anti-VEGF treatments within minimum of 6 months and maximum of 3 years before enrollment of the study
6. Documentation of the presence of subretinal fluid or cystoid oedema less than 30 days since last treatment.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 PDT (Visudyne) 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 6 months of baseline
7. Intraocular surgery in the study eye within 2 months of baseline
8. Prior vitrectomy or other surgical intervention for age-realted macular degeneration in the study eye
9. Current vitreous haemorrhage or inflammation in the study eye
10. Uncontrolled glaucoma I the study eye. Intraocular pressure greater than 30mmHg on maximal medical therapy
11. History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment
12. Allergy to fluorescein and indocyanine green dye.

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 who were diagnosed as age-related macular degeneration and have been previously treated with intravitreal Lucentis or Avastin and despite monthly injections, show persisting fluid in the macula, will be invited to participate at the Sydney Retina Clinic & Day Surgery, Australia.
All subjects will receive 2.0 mg intravitreal aflibercept injection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised 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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 408 0
Sydney Retina Clinic & Day Surgery - Sydney
Recruitment postcode(s) [1] 6175 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 285460 0
Self funded/Unfunded
Name [1] 285460 0
Andrew Chang
Country [1] 285460 0
Australia
Primary sponsor type
Individual
Name
Andrew Chang
Address
Level 13, 187 Macquarie Street
Sydney 2000 NSW Australia
Country
Australia
Secondary sponsor category [1] 284316 0
None
Name [1] 284316 0
Address [1] 284316 0
Country [1] 284316 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287473 0
Ethics committee address [1] 287473 0
Ethics committee country [1] 287473 0
Date submitted for ethics approval [1] 287473 0
27/06/2012
Approval date [1] 287473 0
Ethics approval number [1] 287473 0

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

Contacts
Principal investigator
Name 34328 0
Address 34328 0
Country 34328 0
Phone 34328 0
Fax 34328 0
Email 34328 0
Contact person for public queries
Name 17575 0
Dr Andrew Chang
Address 17575 0
Level 13, 187 Macquarie Street, Sydney, NSW 2000
Country 17575 0
Australia
Phone 17575 0
+61 2 92213755
Fax 17575 0
+61 2 92211637
Email 17575 0
[email protected]
Contact person for scientific queries
Name 8503 0
Dr Andrew Chang
Address 8503 0
Level 13, 187 Macquarie Street, Sydney, NSW 2000
Country 8503 0
Australia
Phone 8503 0
+61 2 92211637
Fax 8503 0
+61 2 92211637
Email 8503 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShort-term effectiveness of intravitreal aflibercept for persistent exudative age-related macular degeneration.2013
EmbaseIntravitreal Aflibercept for Treatment-Resistant Neovascular Age-Related Macular Degeneration: 12-Month Safety and Efficacy Outcomes.2016https://dx.doi.org/10.1159/000440886
EmbaseVision-related quality of life: 12-month aflibercept treatment in patients with treatment-resistant neovascular age-related macular degeneration.2017https://dx.doi.org/10.1007/s00417-016-3477-9
EmbaseLong-term outcomes of switching to aflibercept for treatment-resistant neovascular age-related macular degeneration.2019https://dx.doi.org/10.1111/aos.14046
N.B. These documents automatically identified may not have been verified by the study sponsor.