Subthreshold Laser Treatment in Intermediate Age-related Macular Degeneration With Nascent Geographic Atrophy Study

Prior treatment

• Any other investigational treatment for AMD, excluding dietary supplements, received in the past 12 months or thought, in the opinion of the investigator, likely to chronically change the course of the subject's retinal disease
• History of prior laser surgery to the retina including subthreshold laser (focal retinopexy for a peripheral break and/or focal retinal tears performed more than 90 days prior to the entry into the study is permitted)
• Previous retinal or ocular surgery, the effects of which may now or in the future complicate assessment of the progression of AMD. (Cataract surgery is allowed as long as it was performed over 90 days prior to entry into the study)
• Use of any systemic or ocular medication known to be toxic to the retina, excluding tamoxifen unless there is evidence of toxicity.

Other illness

• Any ocular disease in the study eye, other than AMD, which in the opinion of the investigator may significantly compromise assessment of the retina, or which would compromise the ability to assess any effect following SNL treatment including, but not limited to:
  • Diabetic retinopathy (unless limited to fewer than 10 microaneurysms and/or small retinal hemorrhages, without retinal thickening on OCT)
  • Macular pathology or pigmentary abnormalities atypical of AMD, including but not limited to: pattern dystrophy, myopic maculopathy, angioid streaks, resumed ocular 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, or closer 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 with depigmentation or overlying drusen, if these drusen are used to determine eligibility
  • Active uveitis or ocular inflammation
• Known hypersensitivity to fluorescein
• Corneal pathology precluding visualization of fundus or increasing the risk of using a contact lens, such as corneal dystrophy, recurrent corneal erosion syndrome or sensitivity to the application of a contact lens.

Other

• STUDY EYE: A cluster of definitely present reticular pseudodrusen (RPD) of >1 disc area (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 on the 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 central foveal B-scan
• Any evidence of definite geographic atrophy (GA) in either eye
• Any evidence of active, regressed or treated macular neovascularization (MNV), in either eye, or active peripapillary CNV in the study eye (determined on multi-modal imaging and a fundus fluorescein angiogram is only required if in the investigator's medical judgement) NB: Subretinal fluid (SRF) <100µm or SRF associated with a subfoveal pseudovitelliform lesion permitted (i.e. slither/draping/ vitelliform with no evidence of new vessels on OCT-A) is not considered MNV and can be enrolled.
• Current participation in any other investigational ophthalmological clinical trial
• History or presence of uncontrolled glaucoma
• Intraocular pressure which would preclude safe dilation of the pupil to allow adequate assessment and application of SNL treatment
• Significant cataract or other ocular media which, in the opinion of the investigator, significantly limits the visual acuity or view of the retina
• Sensitivity to application of a contact lens
• Pregnant or lactating women
• Subject who is considered ineligible for this study in the investigator's medical judgement

• Age 50 years or older at time of consent
• Best corrected visual acuity (BCVA) of 59 letters (Snellen equivalent of 6/19) or better in both eyes
• Bilateral large (>125µm) drusen as seen on colour fundus photographs (CFP) as assessed within a circle with radius of 3000µm centred on the fovea
• Between 1 to 5 (inclusive) discrete area/s of nascent geographic atrophy (nGA) as seen on SD-OCT B-scan/s within a 20°x20° volume scan centred on the fovea in the study eye NOTE: TThe non-study eye does not need to have nGA but can have: any number 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 per the study schedule