Phase
Condition
Aging
Macular Degeneration
Myopic Macular Degeneration
Treatment
2RT subthreshold nanosecond laser
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 50 years or older at time of consent
Best corrected visual acuity (BCVA) of 59 letters (Snellen equivalent of 6/19) orbetter in both eyes
Bilateral large (>125µm) drusen as seen on colour fundus photographs (CFP) asassessed within a circle with radius of 3000µm centred on the fovea
Between 1 to 5 (inclusive) discrete area/s of nascent geographic atrophy (nGA) asseen on SD-OCT B-scan/s within a 20°x20° volume scan centred on the fovea in thestudy eye NOTE: TThe non-study eye does not need to have nGA but can have: anynumber of nGA, iRORA or cRORA lesions (on OCT) but not GA (on CFP or FAF)
Ability, willingness and sufficient cognitive awareness to consent to the trial,received randomized SNL treatment or sham procedure, and complete all visits as perthe study schedule
Exclusion
Exclusion Criteria:
STUDY EYE: A cluster of definitely present reticular pseudodrusen (RPD) of >1 discarea (DA) (i.e., an area approximately 2.54mm2 in size) as seen on near infrared (NIR) imaging, or fundus autofluorescence (FAF) within a 20˚x20˚ field centred onthe fovea
STUDY EYE: A subfoveal pigment epithelial detachment (PED)/drusenoid detachment >1000µm in diameter (measured on the central B-scan) with hyperreflective foci (HRF)and increased choroidal transmission or any PED >2000µm measured at the centralfoveal B-scan
Any evidence of definite geographic atrophy (GA) in either eye
Any evidence of active, regressed or treated macular neovascularization (MNV), ineither eye, or active peripapillary CNV in the study eye (determined on multi-modalimaging and a fundus fluorescein angiogram is only required if in the investigator'smedical judgement) NB: Subretinal fluid (SRF) <100µm or SRF associated with asubfoveal pseudovitelliform lesion permitted (i.e. slither/draping/ vitelliform withno evidence of new vessels on OCT-A) is not considered MNV and can be enrolled.
Any other investigational treatment for AMD, excluding dietary supplements, receivedin the past 12 months or thought, in the opinion of the investigator, likely tochronically change the course of the subject's retinal disease
Current participation in any other investigational ophthalmological clinical trial
Any ocular disease in the study eye, other than AMD, which in the opinion of theinvestigator may significantly compromise assessment of the retina, or which wouldcompromise the ability to assess any effect following SNL treatment including, butnot limited to:
Diabetic retinopathy (unless limited to fewer than 10 microaneurysms and/orsmall retinal hemorrhages, without retinal thickening on OCT)
Macular pathology or pigmentary abnormalities atypical of AMD, including butnot limited to: pattern dystrophy, myopic maculopathy, angioid streaks, resumedocular histoplasmosis syndrome, central serous choroidopathy,visually-significant epiretinal membranes, macular hole or pseudohole
Optic nerve pathology, including optic atrophy, history of optic neuropathy
Myopic crescent wider than 50% of the longest diameter of the optic disc, orcloser than 1500 µm to the fovea
Retinal vascular diseases including branch or central vein or artery occlusion
Choroidal nevus within 2 disc diameters (DD) of the fovea associated withdepigmentation or overlying drusen, if these drusen are used to determineeligibility
Active uveitis or ocular inflammation
History or presence of uncontrolled glaucoma
Intraocular pressure which would preclude safe dilation of the pupil to allowadequate assessment and application of SNL treatment
History of prior laser surgery to the retina including subthreshold laser (focalretinopexy for a peripheral break and/or focal retinal tears performed more than 90days prior to the entry into the study is permitted)
Significant cataract or other ocular media which, in the opinion of theinvestigator, significantly limits the visual acuity or view of the retina
Previous retinal or ocular surgery, the effects of which may now or in the futurecomplicate assessment of the progression of AMD. (Cataract surgery is allowed aslong as it was performed over 90 days prior to entry into the study)
Known hypersensitivity to fluorescein
Sensitivity to application of a contact lens
Corneal pathology precluding visualization of fundus or increasing the risk of usinga contact lens, such as corneal dystrophy, recurrent corneal erosion syndrome orsensitivity to the application of a contact lens.
Use of any systemic or ocular medication known to be toxic to the retina, excludingtamoxifen unless there is evidence of toxicity.
Pregnant or lactating women
Subject who is considered ineligible for this study in the investigator's medicaljudgement
Study Design
Connect with a study center
Marsden Eye Specialists
Parramatta, New South Wales 2150
AustraliaSite Not Available
Adelaide Eye & Retina Centre
Adelaide, South Australia 5000
AustraliaSite Not Available
Centre for Eye Research Australia
East Melbourne, Victoria 3002
AustraliaSite Not Available
Retinology Institute
Melbourne, Victoria 3167
AustraliaSite Not Available
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