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Trial registered on ANZCTR


Registration number
ACTRN12617001487303
Ethics application status
Approved
Date submitted
18/10/2017
Date registered
20/10/2017
Date last updated
11/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravitreal Aflibercept for the Treatment of Treatment Resistant Macular Oedema secondary to Retinal Vein Occlusions
Scientific title
A prospective, open-labelled clinical trial to evaluate the efficacy of intravitreal aflibercept for the treatment of treatment resistant macular oedema secondary to retinal vein occlusion
Secondary ID [1] 293153 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
macular oedema secondary to retinal vein occlusion 305129 0
Condition category
Condition code
Eye 304452 304452 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects will initially receive 3 monthly doses of 2.0mg of intravitreal aflibercept injections and then have 2.0mg of intravitreal aflibercept at two monthly intervals for the subsequent 9 months.
Intervention code [1] 299403 0
Treatment: Drugs
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303694 0
To evaluate the effectiveness of aflibercept in maintaining retinal thickness on spectral domain optical coherence tomography (SD-OCT)at week 24.
Timepoint [1] 303694 0
Baseline and week 24
Primary outcome [2] 303709 0
To evaluate the effectiveness of aflibercept in maintaining best corrected visual acuity (BCVA) at week 24.
Timepoint [2] 303709 0
Baseline and week 24
Secondary outcome [1] 339871 0
Proportion of patients who have no macular oedema on SD-OCT at weeks 12, 24 and 48.
Timepoint [1] 339871 0
Baseline, week 12, week 24, week 48
Secondary outcome [2] 339872 0
Mean change in visual acuity at weeks 12, 24 and 48 compared to the baseline as measured by best corrected visual acuity (BCVA) score.
Timepoint [2] 339872 0
Baseline, week 12, week 24, week 48
Secondary outcome [3] 339873 0
Proportion of patients who gain 5, 10 and 15 letters at weeks 12, 24 and 48 as measured on best corrected visual acuity (BCVA)
Timepoint [3] 339873 0
Baseline, week 12, week 24, week 48
Secondary outcome [4] 339874 0
Mean change in central foveal thickness measured by SD-OCT at weeks 12, 24 and 48 compared to the baseline.
Timepoint [4] 339874 0
Baseline, week 12, week 24, week 48
Secondary outcome [5] 339875 0
Mean change in macular fluorescein angiographic leakage at weeks 24 and 48 compared to the baseline.
Timepoint [5] 339875 0
Baseline, week 24, week 48
Secondary outcome [6] 339876 0
Mean change in peripheral capillary closure on wide-field fluorescein angiography on at weeks 24 and 48 compared to the baseline.
Timepoint [6] 339876 0
Baseline, week 24, week 48
Secondary outcome [7] 339877 0
Mean change of capillary diameters on wide-field photography at weeks 24 and 48 compared to the baseline.
Timepoint [7] 339877 0
Baseline, week 24, week 48
Secondary outcome [8] 339878 0
The change of retinal function measured by Macular Integrity Assessment (MAIA) at weeks 24 and 48 compared to the baseline.
Timepoint [8] 339878 0
Baseline, week 24, week 48
Secondary outcome [9] 339879 0
Mean change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) score between baseline and weeks 24 and 48.
Timepoint [9] 339879 0
Baseline, week 24, week 48
Secondary outcome [10] 339945 0
Mean change in central foveal volume measured by SD-OCT at weeks 12, 24 and 48 compared to the baseline.
Timepoint [10] 339945 0
Baseline, week 12, week 24, week 48.

Eligibility
Key inclusion criteria
• Ability to provide informed consent and complete study assessments
• Age 18 years or older
• Macular oedema involving central macula secondary to ischemic or non-ischemic BRVO in study eye
• Best corrected baseline visual acuity between 20-73 letters on ETDRS chart (Snellen equivalent 6/12 to 6/120) in the study eye.
• Presence of central oedema (intra-retinal or sub-retinal fluid) on SD-OCT after at least 4 anti-VEGF treatments within 6 months.
• Documentation of the presence of macular oedema at least 30 days since last treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
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.
• Current vitreous haemorrhage or inflammation in the study eye
• Uncontrolled glaucoma in the study eye defined as intraocular pressure greater than 30mmHg on maximal medical therapy
• grid or a foveal avascular zone greatest linear diameter of > 1000 microns
• Loss of vision or macular oedema due to other causes (e.g. age related macular degeneration, myopic macular degeneration, vitreous traction)
• An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy).
• Severe media opacity impeding the view of the fundus.
• History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrolment.
• Allergy to fluorescein dye.
• Uncontrolled diabetes mellitus, as defined by haemoglobin A1C (HbA1c) > 12%.
• 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 macular oedema secondary to retinal vein occlusion who have been previously treated with intravitreal anti-VEGF therapy with a minimum of 4 consecutive injections within the 6 months, will be invited to participate at Sydney Retina Clinic 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)
Safety/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
Actual
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] 9201 0
Sydney Retina Clinic & Day Surgery - Sydney
Recruitment postcode(s) [1] 17854 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 297780 0
Commercial sector/Industry
Name [1] 297780 0
Bayer Australia Limited
Address [1] 297780 0
875 Pacific Highway, Pymble NSW 2073
Country [1] 297780 0
Australia
Primary sponsor type
Individual
Name
A/Prof Andrew Chang
Address
Level 13 Park House, 187 Macquarie Street Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 296818 0
None
Name [1] 296818 0
Address [1] 296818 0
Country [1] 296818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298839 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 298839 0
129 Glen Osmond Road
Eastwood, SA 5063
Ethics committee country [1] 298839 0
Australia
Date submitted for ethics approval [1] 298839 0
23/10/2017
Approval date [1] 298839 0
10/01/2018
Ethics approval number [1] 298839 0
2017-11-837

Summary
Brief summary
This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for macular oedema secondary to retinal vein occlusion 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
www.sydneyretina.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78402 0
A/Prof Andrew Chang
Address 78402 0
Sydney Retina Clinic and Day Surgery
Level 13, Park House
187 Macquarie Street
Sydney, NSW 2000
Country 78402 0
Australia
Phone 78402 0
+61 2 9221 3755
Fax 78402 0
+61 2 9221 1637
Email 78402 0
achang@sydneyretina.com.au
Contact person for public queries
Name 78403 0
Miss Kimberly Spooner
Address 78403 0
Sydney Retina Clinic and Day Surgery
Level 13, Park House
187 Macquarie Street
Sydney, NSW 2000
Country 78403 0
Australia
Phone 78403 0
+61 2 9221 3755
Fax 78403 0
+61 2 9221 1637
Email 78403 0
kspooner@sydneyretina.com.au
Contact person for scientific queries
Name 78404 0
A/Prof Andrew Chang
Address 78404 0
Sydney Retina Clinic and Day Surgery
Level 13, Park House
187 Macquarie Street
Sydney, NSW 2000
Country 78404 0
Australia
Phone 78404 0
+61 2 9221 3755
Fax 78404 0
+61 2 9221 1637
Email 78404 0
achang@sydneyretina.com.au

No information has been provided regarding IPD availability
Summary results
No Results