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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Laser Treatment
Centre for Eye Research Australia - Royal Victorian Eye & Ear Hospital
East Melbourne, Victoria, Australia
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
Time frame: up to 48 weeks
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
Time frame: 24 weeks and 48 weeks post-treatment
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