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

May 14, 2023 updated by: Lutronic Vision, Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser Treatment
Laser treatment using the R:GEN Laser System on Day 1 and at Week 24
Device: R:GEN Laser System
Laser Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Evidence of the presence of late AMD
24 weeks and 48 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lutronic Vision, Inc

Collaborators

Neuroscience Trials Australia

Investigators

  • Principal Investigator: Robyn H Guymer, MBBS, PhD, Center for Eye Research Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

March 14, 2023

Study Completion (Actual)

March 14, 2023

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56173

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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