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

NCT04776031 | Completed DMC

• 1 other identifier: 56173
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Age Related Macular Degeneration (Disorder)

Keywords

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; High risk early age related macular degeneration; Laser Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  24 weeks and 48 weeks post-treatment

Study Arms (1)

Laser Treatment

EXPERIMENTAL

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

Device: R:GEN Laser System

Interventions

R:GEN Laser System DEVICE

Laser Treatment

Laser Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lutronic Vision, Inc: lead
• Neuroscience Trials Australia: collaborator

Study Sites (1)

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

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary

Study Officials

• Robyn H Guymer, MBBS, PhD

  Center for Eye Research Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: February 15, 2021
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

AU (1)