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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04776031




Registration number
NCT04776031
Ethics application status
Date submitted
25/02/2021
Date registered
1/03/2021
Date last updated
16/05/2023

Titles & IDs
Public title
Evaluation of R:GEN as Intervention in Subjects With Early Stages of AMD for Safety and Exploratory Efficacy Outcomes
Scientific title
Evaluation of the R:GEN Laser System as an Intervention in Subjects With Early Stages of Age Related Macular Degeneration (AMD) for Safety and Exploratory Efficacy Outcomes
Secondary ID [1] 0 0
56173
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - R:GEN Laser System

Experimental: Laser Treatment - Laser treatment using the R:GEN Laser System on Day 1 and at Week 24


Treatment: Devices: R:GEN Laser System
Laser Treatment
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To access the safety and tolerability of the R:GEN Laser System in subjects with the early stages of AMD.
Timepoint [1] 0 0
up to 48 weeks
Secondary outcome [1] 0 0
To evaluate the progression in severity of AMD after treatment with the R:GEN Laser System at 24 weeks and 48 weeks post-treatment.
Timepoint [1] 0 0
24 weeks and 48 weeks post-treatment

Eligibility
Key inclusion criteria
- Adults 50 years and over

- Best Corrected Visual Acuity [BCVA] of 6/12 [20/40] or better in each eye

- Bilateral large drusen: at least 1 druse =125 µm in each eye within an inner macular
zone [a circle with a radius of 1500 µm centered on the fovea], and with or without
pigment;

- Ability and willingness to consent, receive laser treatment, and complete all visits
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any evidence of definite reticular pseudo drusen [RPD] > 2-disc areas [DAs] as seen
either by fundus autofluorescence [FAF] or near-infrared reflectance [NIR] enface
imaging in each eye

- Any evidence of geographic atrophy [GA] within the macula [a circle with a radius of
3000 microns centered on the fovea] excluding peripapillary atrophy

- Any evidence of nascent GA, or worse evidence of atrophy (complete RPE and outer
retinal atrophy) as determined by OCT: including the subsidence of the inner nuclear
layer and outer plexiform layer [OPL], or the presence of a hypore?ective wedge-shaped
band within the limits of the OPL, and accompanied by attenuation or absence of the
RPE and hypertransmission into the choroid

- Current choroidal neovascularization [CNV], (determined on multimodal imaging [MMI],
but angiogram not required) or past evidence of CNV, including the presence of
non-exudative macular neovascularization [NE-MNV] [determined by OCT-A]

- Asymptomatic sub-retinal fluid [SRF] [a slither < 50 µm allowed]

- Any current ocular disease or condition in the study eye including diseases affecting
the optic nerve, the anterior chamber, and autoimmune or systemic inflammatory
conditions in which there are ocular manifestations that either are undergoing or
require treatment, or history of ocular disease within 3 months of screening

- A central macular serous pigment epithelial detachment greater than 1000 µm in
diameter; a central macular drusenoid detachment > 1000 µm with hyper reflective foci
[HRF] and hypertransmission; or any central macular drusenoid pigment epithelial
detachments >2000 µm

- Previous retinal or ocular surgery within 3 months prior to screening, the effects of
which may now or in the future complicate assessment of AMD

- Any history of prior laser treatment to the retina

- Any systemic medication known to be toxic to the retina

- Known hypersensitivity to fluorescein or indocyanine green

- Sensitivity to application of a contact lens

- History or presence of uncontrolled glaucoma, ocular hypertension, or intraocular
pressure > 24 mmHg

- Cataract which in the opinion of the investigator limits evaluation of the retina or
requires cataract surgery within 12 months

- Pregnant or lactating women

- Subject who is currently in a clinical study, or has received other active
investigational therapy, within 30 days of the screening visit

- Subject who is considered ineligible for this study in the investigator's medical
judgment

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/03/2023
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lutronic Vision, Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Neuroscience Trials Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of the R:GEN Laser System
in subjects with the early stages of age-related macular degeneration.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04776031
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robyn H Guymer, MBBS, PhD
Address 0 0
Center for Eye Research Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04776031