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Evaluation of R:GEN as Intervention in Subjects With Early Stages of AMD for Safety and Exploratory Efficacy Outcomes

Primary Purpose

Early Age Related Macular Degeneration (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
R:GEN Laser System
Sponsored by
Lutronic Vision, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Age Related Macular Degeneration (Disorder) focused on measuring Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, High risk early age related macular degeneration, Laser Treatment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 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
  • 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

Sites / Locations

  • Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 25, 2021
Last Updated
May 14, 2023
Sponsor
Lutronic Vision, Inc
Collaborators
Neuroscience Trials Australia
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1. Study Identification

Unique Protocol Identification Number
NCT04776031
Brief Title
Evaluation of R:GEN as Intervention in Subjects With Early Stages of AMD for Safety and Exploratory Efficacy Outcomes
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
March 14, 2023 (Actual)
Study Completion Date
March 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lutronic Vision, Inc
Collaborators
Neuroscience Trials Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Age Related Macular Degeneration (Disorder)
Keywords
Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, High risk early age related macular degeneration, Laser Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Treatment
Arm Type
Experimental
Arm Description
Laser treatment using the R:GEN Laser System on Day 1 and at Week 24
Intervention Type
Device
Intervention Name(s)
R:GEN Laser System
Intervention Description
Laser Treatment
Primary Outcome Measure Information:
Title
To access the safety and tolerability of the R:GEN Laser System in subjects with the early stages of AMD.
Description
Incidences of Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Serious Adverse Device Effects
Time Frame
up to 48 weeks
Secondary Outcome Measure Information:
Title
To evaluate the progression in severity of AMD after treatment with the R:GEN Laser System at 24 weeks and 48 weeks post-treatment.
Description
Evidence of the presence of late AMD
Time Frame
24 weeks and 48 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn H Guymer, MBBS, PhD
Organizational Affiliation
Center for Eye Research Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Evaluation of R:GEN as Intervention in Subjects With Early Stages of AMD for Safety and Exploratory Efficacy Outcomes

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