Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001315101
Ethics application status
Approved
Date submitted
3/09/2019
Date registered
26/09/2019
Date last updated
28/04/2024
Date data sharing statement initially provided
26/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical study to evaluate the safety and feasibility of the OcuDyne system in the treatment of age-related macular degeneration (AMD)
Scientific title
A clinical study to evaluate the safety and feasibility of the OcuDyne system in the treatment of age-related macular degeneration (AMD)
Secondary ID [1] 299161 0
Sponsor: Protocol OC-1901
Universal Trial Number (UTN)
U1111-1239-5867
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Age-Related Macular Degeneration 314264 0
Condition category
Condition code
Eye 312619 312619 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary study objective is to evaluate the safety and feasibility of the OcuDyne Ophthalmic Micro Balloon Angioplasty System in subjects with nonexudative age-related macular degeneration.
This study is being conducted to test a new interventional micro balloon angioplasty procedure to increase choroidal blood supply. The feasibility of the procedure is presented due to the historically successful use of small artery cerebral angioplasty and ophthalmic artery (OA) angioplasty for acute ischemic retinopathy using like instrumentation. The OcuDyne #OC-1901 project is an effort to confirm the safety and feasibility of reaching and treating the target anatomy to treat the condition Age-related macular degeneration (AMD) with specialty devices made for this purpose.
Device intervention (Ocudyne Ophthalmic Micro Balloon Angioplasty System) will be utilized in the OcuDyne #OC-1901 project. The system is composed of the following components:
Aiming Microcatheter (AMC); Over the Wire (OTW)
Aiming Microcatheter (AMC); Rapid Exchange (RX)
Micro Balloon Catheter (MBC); Rapid Exchange (RX)

The angioplasty procedure is expected to take approximately 30 - 60 minutes and is performed by neuro-interventionists that have extensive experience performing endovascular procedures. The study procedure is conducted in a neurovascular imaging suite under fluoroscopic visualization by inserting (via percutanious femoral access), utilizing commercially available and commonly used (for this purpose) devices to access the arteries. The study doctor accesses the area near the ophthalmic artery, the OcuDyne Ophthalmic Micro Balloon Angioplasty System will be used to enter the ophthalmic artery. One device (Aiming Micro Catheter) helps access the artery (Investigator choice of two common styles of like devices: Over the Wire (OTW) or Rapid Exchange (RX)); the second device (Micro Balloon Catheter - Investigator choice of size based on subject anatomy) is a wire with a tiny inflatable balloon at the end that is placed in the entrance of the ophthalmic artery. As the balloon is inflated, the blood vessel is opened.
The details and information produced as part of this project will be careful documented and collected to analyze. All information will be continually monitored and audited throughout the study to ensure accuracy and subject safety.
Intervention code [1] 315467 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321276 0
Procedure related complications. Potential complications are estimated to be rare based on similar procedures and could include vascular occlusion, adverse response to anesthesia, allergic response to contrast dye, embolism, arterial perforation or rupture, spasm in the treated blood vessel.
Timepoint [1] 321276 0
Intraoperative through Week 4. Patients will be carefully monitored during the procedure for potential complications and treated immediately as needed. The potential for intraoperative or delayed events up to week 4 postoperative are estimated to be rare based on similar procedures and could include entry site bruising or bleeding, embolism, or changes in vision. Patients are carefully monitored and asked to complete an "Impact of Vision Impairment Profile" questionnaire at each visit. The patients are evaluated for this endpoint at day 2, week 1, week 4, and as needed during the first 4 weeks postoperative. In addition, patients are asked to report any untoward events or concerns whether thought to be relevant or not.
Secondary outcome [1] 374510 0
Incidence of Adverse Events Potential adverse events associated with the study are considered rare and could include reactions to eye drops used in the study, allergic reaction to fluorescein used in ophthalmic imaging, changes in vision, or worsening of condition under treatment (age related macular degeneration), Patients are carefully monitored and asked to complete an "Impact of Vision Impairment Profile" questionnaire at each visit. Patients are evaluated at day 2, week 1, week 4, month 3, month 6, and as needed following the study procedure. In addition, patients are asked to report any untoward events or concerns whether thought to be relevant or not throughout study participation.
Timepoint [1] 374510 0
Patients will be monitored for this endpoint at Day 2, Week 1, Week 4, Month 3, and Month 6 time points following the study procedure (during entire follow-up period of study participation)
Secondary outcome [2] 374511 0
Procedural Success using the OcuDyne Ophthalmic Percutaneous Transluminal Catheter (OPTiC) System. Procedural success is defined by the following three criteria: 1. Access to the internal carotid artery, access to the ophthalmic artery, balloon angioplasty of the ophthalmic artery completed. If all three criteria are not met, the treatment will be considered a treatment failure.
Timepoint [2] 374511 0
The Operative Visit will be when this outcome is assessed for success or failure. The three criteria listed above must be achieved during the course of the study procedure itself.

Eligibility
Key inclusion criteria
1. Adults at least 60 years of age at the time of consent
2. Diagnosed with non-exudative Age-Related Macular Degeneration with current or previous evidence of at least one large drusen (measuring 125 microns or greater) and nascent geographic atrophy (nGA) or GA in the study eye
3. ETDRS BCDVA letter score of between 55 and 20 letters (Snellen equivalent of 20/80 to 20/400) in the study eye, which in the Investigator’s judgment is caused by non-exudative AMD
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any surgical intraocular treatment (including laser) within 3 months in the study eye.
2. History of exudative AMD or Anti-Vascular Endothelial Growth Factor (anti-VEGF) injections in the study eye.
3. Presence of ocular media affecting visual acuity or the ability to visualize the retina in either eye (e.g. central corneal scarring, lens opacities along visual axis, posterior capsule opacification, etc.).
4. History of chronic, recurring inflammatory eye disease in either eye (e.g., scleritis, uveitis, corneal edema, etc.)
5. Presence of diabetic retinopathy in either eye.
6. Evidence of macular edema secondary to exudation in the study eye.
7. History of amaurosis fugax, central or retinal artery or vein occlusion, anterior ischemic optic neuropathy (AION) or non-arteritic anterior ischemic optic neuropathy (NAION) in the study eye.
8. Myopia > 6.0 Diopters (D) or Axial Length equal to or greater than 26.0 mm in the study eye.
9. Presence of visually significant epiretinal membrane in the study eye.
10. Participation in any eye-related drug or device clinical trial involving either eye within 90 days prior to enrolling in this study and/or during study participation.
11. Any condition that prohibits the use of intravenous contrast agents (e.g. renal insufficiency, previous anaphylactoid reaction to contrast material, treatment with nephrotoxic agents, etc.).
12. Previous stroke, including ischemic, hemorrhagic or transient ischemic attack (TIA).
13. Previous myocardial infarction (MI), including ST segment elevation (STEMI), non-ST segment elevation (NSTEMI) or coronary spasm/angina.
14. Coronary or other intravascular percutaneous procedure, including balloon angioplasty, stent or filter placement within 6 months.
15. Presence of cranial aneurysm, clinically significant stenosis in common carotid artery or internal carotid artery, or tortuous vascular anatomy as seen on pre-procedural CT Angiogram that, in the clinical judgement of the investigator, represents an unreasonable risk to perform the intervention.
16. Condition associated with increased bleeding risk including but not limited to: major surgical procedure or trauma within 30 days of screening; clinically significant gastrointestinal bleeding within 1 year of screening; known gastric or duodenal ulcer; history of intracranial or spinal bleeding; chronic hemorrhagic disorder; treatment with oral anticoagulant medications (e.g., Warfarin / non-vitamin K anticoagulants [NOACs] exclusionary; aspirin or clopidogrel allowed), known intracranial neoplasm, arteriovenous malformation, or aneurysm.
17. Sustained and uncontrolled hypertension with systolic blood pressure > 180 mmHg.
18. Diagnosis of moderate to severe symptomatic chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD)
19. Diagnosis of connective tissue disease (e.g., lupus, rheumatoid arthritis, scleroderma, etc.).
20. Intolerance of either pre- or post- procedure medication regimen.
21. Pregnancy, lactation, or plans to become pregnant during participation in this clinical trial.
22. Participation in any other non-eye related drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.
23. Use of facial fillers or paralytic drugs during study participation.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
No imputation for missing data will be performed. Descriptive statistics will be used to summarize the data, including baseline characteristics and study endpoints. Results will be presented separately by eye for the Safety Population, Treated-Eye Population, the Fellow-Eye Population, and where appropriate, for the difference between Study eye and Fellow Eye.
Continuous variables will be summarized by mean, standard deviation, median, minimum and maximum. Categorical variables will be summarized by frequency and percentage. Nominal 95% confidence intervals (without adjustment for multiplicity) may be used to quantify uncertainty, based on the t-distribution for continuous variables and the binomial distribution (exact intervals) for binary variables. Analysis of change will be based on the change from screening/baseline to the corresponding follow-up time point (i.e. Day 1, Week 1, etc., up to Month 6).
Potential analyses include time-to-event analysis (Kaplan-Meier analysis) for adverse events and repeated measures regression models for characterizing change in exploratory endpoints over time. Repeated measures models will account for within-subject correlation.
Additionally, exploratory analyses may be performed in an ad hoc fashion to further understand the study data, to inform future procedure or device refinements, and to inform future clinical studies.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/11/2020
Actual
15/12/2020
Date of last participant enrolment
Anticipated
30/06/2023
Actual
19/03/2021
Date of last data collection
Anticipated
31/01/2024
Actual
13/04/2024
Sample size
Target
30
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14715 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [2] 14716 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 27755 0
3002 - East Melbourne
Recruitment postcode(s) [2] 27756 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 303702 0
Commercial sector/Industry
Name [1] 303702 0
OcuDyne Australia Pty Ltd
Country [1] 303702 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OcuDyne Australia Pty Ltd
Address
Level 13, 41 Exhibition Street
Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 303829 0
None
Name [1] 303829 0
Address [1] 303829 0
Country [1] 303829 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304227 0
Monash Health HREC
Ethics committee address [1] 304227 0
Monash Health
Level 2, I Block,
246 Clayton Road
Clayton, VIC 3168
Ethics committee country [1] 304227 0
Australia
Date submitted for ethics approval [1] 304227 0
18/09/2019
Approval date [1] 304227 0
11/03/2020
Ethics approval number [1] 304227 0

Summary
Brief summary
The main objective of this study is to evaluate the safety and feasibility of the OcuDyne Ophthalmic Micro Balloon Angioplasty System in subjects with dry age-related macular degeneration (AMD). Currently there is no treatment available for dry AMD and this device system may offer a potentially effective treatment.
The study is first in human and is a prospective, open label, feasibility clinical trial. This multi-center trial will be conducted at up to six sites in Australia and aims to enroll and treat up to 30 subjects. This study involves a 60 day screening period, study procedure, overnight observation, and follow-up visits (Day 2, Week 1, Week 4, Months 3, Months 6). The study duration for each participant is approximately 8 months.

The feasibility of the procedure is presented due to the historically successful use of small artery cerebral angioplasty and ophthalmic artery (OA) angioplasty for acute ischemic retinopathy using like instrumentation. The OcuDyne #OC-1901 project is an effort to confirm the feasibility of establishing the presence of OA ostium narrowing intraoperatively and further, to establish the ability to treat the condition of dry AMD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96202 0
A/Prof Ronil Chandra
Address 96202 0
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country 96202 0
Australia
Phone 96202 0
+61 437 169 667
Fax 96202 0
Email 96202 0
ronil.chandra@monashhealth.org
Contact person for public queries
Name 96203 0
Ms Emily Caruso
Address 96203 0
Centre for Eye Research Australia
Level 7, 32 Gisborne Street
EAST MELBOURNE VIC 3002
Country 96203 0
Australia
Phone 96203 0
+61 399 298 113
Fax 96203 0
Email 96203 0
emily.caruso@unimelb.edu.au
Contact person for scientific queries
Name 96204 0
A/Prof Ronil Chandra
Address 96204 0
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Country 96204 0
Australia
Phone 96204 0
+61 437 169 667
Fax 96204 0
Email 96204 0
ronil.chandra@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will provided in aggregate only in the context of a final report.


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
No additional documents have been identified.