Early Age Related Macular Degeneration (Disorder)NCT04776031
Evaluation of R:GEN as Intervention in Subjects With Early Stages of AMD for Safety and Exploratory Efficacy Outcomes
A study testing R:GEN Laser System in people with Early Age Related Macular Degeneration (Disorder), run by Lutronic Vision, Inc at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Early Age Related Macular Degeneration (Disorder)
- What is being tested?
- R:GEN Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Feb 2021to 14 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 hyporeflective 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital
East Melbourne, Victoria, 3002
About this study
Official 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
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.
Read the detailed description
This clinical study is a prospective, single-center, single-arm, open-label, pilot study to evaluate the safety and tolerability of the R:GEN Laser System and to collect information on the severity of AMD in subjects with bilateral large drusen. All participants will receive the intervention at the baseline visit and at the 24-week visit. All participants will be evaluated at 24 and 48 weeks from the baseline visit.
- Being tested
- R:GEN Laser System
- Keywords
- Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, High risk early age related macular degeneration, Laser Treatment
- Medical subject headings
- Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R:GEN Laser SystemDevice
Laser Treatment
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment | Experimental | Laser treatment using the R:GEN Laser System on Day 1 and at Week 24 Receives: Device: R:GEN Laser System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To access the safety and tolerability of the R:GEN Laser System in subjects with the early stages of AMD.
Incidences of Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Serious Adverse Device Effects
Measured: up to 48 weeks
Secondary outcomes (1)
To evaluate the progression in severity of AMD after treatment with the R:GEN Laser System at 24 weeks and 48 weeks post-treatment.
Evidence of the presence of late AMD
Measured: 24 weeks and 48 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start15 Feb 2021
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Age Related Macular Degeneration (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lutronic Vision, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neuroscience Trials Australia
- Responsible party
- Sponsor
- Investigators
- Robyn H Guymer, MBBS, PhD, Principal investigator, Center for Eye Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776031
- Sponsor's protocol ID
- 56173
- Status last verified
- May 2023
- First submitted
- 25 Feb 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04776031
- Acronym / sponsor ID
- 56173
- Keywords
- Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, High risk early age related macular degeneration, Laser Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lutronic Vision, IncIndustry (pharma, biotech, devices)
- Collaborators
- Neuroscience Trials Australia
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical study is a prospective, single-center, single-arm, open-label, pilot study to evaluate the safety and tolerability of the R:GEN Laser System and to collect information on the severity of AMD in subjects with bilateral large drusen. All participants will receive the intervention at the baseline visit and at the 24-week visit. All participants will be evaluated at 24 and 48 weeks from the baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment | Experimental | Device: R:GEN Laser SystemLaser treatment using the R:GEN Laser System on Day 1 and at Week 24 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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 hyporeflective 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R:GEN Laser SystemLaser Treatment | Device | Laser Treatment |
Primary outcome
To access the safety and tolerability of the R:GEN Laser System in subjects with the early stages of AMD.
Time frame: up to 48 weeks
Incidences of Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Serious Adverse Device Effects
1 secondary outcome
To evaluate the progression in severity of AMD after treatment with the R:GEN Laser System at 24 weeks and 48 weeks post-treatment.
Time frame: 24 weeks and 48 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn H Guymer, MBBS, PhD principal investigator
Center for Eye Research Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R:GEN Laser System in people with Early Age Related Macular Degeneration (Disorder), run by Lutronic Vision, Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To access the safety and tolerability of the R:GEN Laser System in subjects with the early stages of AMD. (time frame: up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.