Eligibility |
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 hypore?ective 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
|