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Trial registered on ANZCTR


Registration number
ACTRN12618001308280
Ethics application status
Approved
Date submitted
27/07/2018
Date registered
3/08/2018
Date last updated
29/11/2021
Date data sharing statement initially provided
10/07/2019
Date results provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to determine the safety and tolerability of an intravitreal steroid in the treatment of dry Age Related Macular Degeneration.
Scientific title
A Phase Ib, study of safety and tolerability if Intravitreal Fludrocortisone Acetate (FCA) in patients with Geographic Atrophy (GA)
Secondary ID [1] 298696 0
FA4GA 1B
Universal Trial Number (UTN)
U1111-1218-2056
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy secondary to Age Related Macular Degeneration 309041 0
Condition category
Condition code
Eye 307931 307931 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Determine safety and tolerability of a single dose intravitreal (IVT) injection of 4mg/0.1 mL fludrocortisone acetate, applied by a registered ophthalmologist in subjects with geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).

Intervention code [1] 301995 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306905 0
1..Demonstrate safety and tolerability of intravitreal injections of fludrocortisone acetate based upon the mean change in geographic lesion size as measured by Fundus Autofluorescence (FAF).
Timepoint [1] 306905 0
Participants will participate in a screening period of up to 14 days and a follow-up period of 28 days. Participants will subsequently be followed for another 140 days. A total of 8 visits will take place. Assessment will take place on Day 0, Day 1, Day 7, Day 14, Day 28, Day 56, Day 84, Day 168
Primary outcome [2] 306928 0
Number and severity of local and systemic treatment emergent adverse events. All adverse events (AEs), either observed by the Principal Investigator (PI) or one of their medical collaborators, or reported by the participant spontaneously, or in response to direct questioning, will be reported at each study visit. All adverse events (ocular, non-ocular, serious, non-serious, volunteered, and elicited) will be documented in study records. All AEs will be followed up and data clarified from medical records or correspondence from other medical practitioners/hospitals.
Timepoint [2] 306928 0
Participants will participate in a screening period of up to 14 days and a follow-up period of 28 days. Participants will subsequently be followed for another 140 days. A total of 8 visits will take place. .Assessment will take place on Day 0, Day 1, Day 7, Day 14, Day 28, Day 56, Day 84, Day 168
Secondary outcome [1] 350058 0
• Geographic atrophy (GA) lesion size from baseline to Month 6 as measured by FAF.
Timepoint [1] 350058 0
Participants will participate in a screening period of up to 14 days and a follow-up period of 28 days. Participants will subsequently be followed for another 140 days. A total of 8 visits will take place. Assessment will take place on Day 0, Day 1, Day 7, Day 14, Day 28, Day 56, Day 84, Day 168
Secondary outcome [2] 350141 0
Change in best corrected visual acuity (BCVA) and low luminance best corrected visual acuity (LL-BCVA)(composite outcome)..Best-corrected visual acuity (including LL-BCVA) testing, performed by a certified VA examiner, and will precede any examination requiring administration of eye drops to dilate the eye or any examination requiring contact with the eye. The number of letters read correctly (for each eye) will be recorded in the appropriate study document
Timepoint [2] 350141 0
Participants will participate in a screening period of up to 14 days and a follow-up period of 28 days. Participants will subsequently be followed for another 140 days. A total of 8 visits will take place. Assessment will take place on Day 0, Day 1, Day 7, Day 14, Day 28, Day 56, Day 84, Day 168.
Secondary outcome [3] 350143 0
Intra-ocular pressure (IOP). This will be measured by Goldmann Appamation Tonometry
Timepoint [3] 350143 0
Participants will participate in a screening period of up to 14 days and a follow-up period of 28 days. Participants will subsequently be followed for another 140 days. A total of 8 visits will take place. Assessment will take place on Day 0, Day 1, Day 7, Day 14, Day 28, Day 56, Day 84, Day 168

Eligibility
Key inclusion criteria
Study population will comprise of patients with Geographic Atrophy(GA) secondary to Age Related Macular Degeneration (AMD) in both eyes with no previous treatment.
Unless specified otherwise, ocular specific inclusion criteria apply to the study eye only.
1. Willing and able to give consent prior to any specific procedures being performed.
2. Male or Female.
3. Minimum age 50 years.
4. Best corrected visual acuity (BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (20/320 Snellen equivalent).
5. Diagnosis of GA of the macula secondary to AMD in both eyes, confirmed within 14 days prior to dosing by the PI using Fundus Autofluorescence (FAF) images, as well as the following criteria:
a. Total GA area must be greater than or equal to 1.9 and less than or equal to 17 mm2 (1 and 7 disc areas (DA) respectively), determined by screening images of FAF.
b. If GA is multifocal, at least one focal lesions must be greater than or equal to 1.25 mm2 (0.5 DA).
c. GA can be completely visualized on the macula centered image.
d. GA must be able to be photographed in its entirety.
e. GA must be able to be measured separately from any areas of peripapillary atrophy.
f. Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
6. Female subjects must be:
a. Women of non-childbearing potential (WONCBP), nursing or
b. Women of childbearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study.
7. Males with female partners of childbearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
8. Willing and able to give informed consent.

Note: If both eyes meet the inclusion criteria, the eye with the best visual acuity at the screening visit will be designated as the study eye. If both eyes have the same visual acuity, the right eye will be used as the study eye.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ocular specific exclusion criteria apply to the study eye only.
1. GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like plaquenil maculopathy.
2. Spherical equivalent of the refractive error demonstrating > 6 dioptres of myopia or an axial length of >26 mm.
3. Any history of current evidence of exudative (wet) AMD including evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere in the retina based on fluorescein angiogram as assessed by the PI in either eye.
4. Retinal disease likely to confound visual performance or be affected by intraocular steroid.
5. Any ophthalmologic condition that reduces clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination (e.g. advanced cataract or corneal abnormalities).
6. Any ophthalmologic condition that prevents adequate imaging of the retina judges by the PI.
7. Intraocular surgery (including lens replacement surgery) within 3 months prior to dosing.
8. Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to Day 0.
9. Any ophthalmologic condition that may require surgery during the study period.
10. Uncontrolled glaucoma defined as intraocular pressure >25 mmHg on maximal therapy.
11. Any contraindication of IVT injection including current ocular or periocular infection.
12. History of uveitis or endophthalmitis.
13. History of choroidal neovascularization (CNV) in either eye.
14. History of IVT injection at any time.
15. Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 6 weeks or 5 half-lives of the active (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
16. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the study period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.
17. Any screening laboratory value (haematology, serum chemistry or urinalysis) that in the opinion of the investigator is clinically significant and not suitable for study participation.
18. History or current evidence of hypersensitivity to any components of the study medication or fluorescein.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/12/2018
Actual
4/07/2019
Date of last participant enrolment
Anticipated
16/04/2021
Actual
26/04/2021
Date of last data collection
Anticipated
Actual
24/09/2021
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23549 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 300231 0
Commercial sector/Industry
Name [1] 300231 0
Eye Co Pty Ltd
Country [1] 300231 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Eye Co Pty Ltd
Address
Level 1, 70 Doncaster Road
Balwyn North VIC 3104, Australia
Country
Australia
Secondary sponsor category [1] 299686 0
None
Name [1] 299686 0
None
Address [1] 299686 0
Country [1] 299686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301054 0
Bellberry Limited
Ethics committee address [1] 301054 0
Ethics committee country [1] 301054 0
Australia
Date submitted for ethics approval [1] 301054 0
17/08/2018
Approval date [1] 301054 0
12/11/2018
Ethics approval number [1] 301054 0

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

Contacts
Principal investigator
Name 85726 0
Dr Dr Andrew Chang
Address 85726 0
Sydney Retina Clinic & Day Surgery
13/187 Macquarie Street, Sydney, NSW, 2000,
Country 85726 0
Australia
Phone 85726 0
+61 2 92213755
Fax 85726 0
+61 2 92211637
Email 85726 0
achang@sydneyretina.com.au
Contact person for public queries
Name 85727 0
Dr Andrew Chang
Address 85727 0
Sydney Retina Clinic & Day Surgery
13/187 Macquarie Street, Sydney, NSW, 2000,
Country 85727 0
Australia
Phone 85727 0
+61 2 92213755
Fax 85727 0
+61 2 92211637
Email 85727 0
achang@sydneyretina.com.au
Contact person for scientific queries
Name 85728 0
Dr Andrew Chang
Address 85728 0
Sydney Retina Clinic & Day Surgery
13/187 Macquarie Street, Sydney, NSW, 2000,
Country 85728 0
Australia
Phone 85728 0
+61 2 92213755
Fax 85728 0
+61 2 92211637
Email 85728 0
achang@sydneyretina.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual de-identified data for all participants within peer reviewed publications will be available or shared. Please note that this is a Phase 1B safety study involving just 10 patients and no statistical data is expected to be generated.
When will data be available (start and end dates)?
Data will be available immediately following publication and will be available indefinitely.
Available to whom?
Pubic access to peer reviewed journals
Available for what types of analyses?
Descriptive safety analyses
How or where can data be obtained?
De-identified data within peer reviewed journals


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
219Ethical approval    375667-(Uploaded-13-11-2018-10-16-28)-Study-related document.pdf
11161Study protocolStudy Protocol Version1.3, drafted by A Prof Andrew Chang p.abrahamson@eyeco.com.au 375667-(Uploaded-16-07-2020-09-25-05)-Study-related document.pdf
11162Informed consent form  p.abrahamson@eyeco.com.au 375667-(Uploaded-16-07-2020-09-33-10)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhase 1B study of the safety and tolerability of the mineralocorticoid fludrocortisone acetate in patients with geographical atrophy.2022https://dx.doi.org/10.1136/bmjophth-2022-001032
N.B. These documents automatically identified may not have been verified by the study sponsor.