| Participants |
Inclusion criteria:
Men or women aged 50‐95 years at the time of consent BCVA of 6/12 (20/40) or better in each eye Bilateral high‐risk early AMD: at least 1 druse ≥ 125 μm within an inner macular zone (a circle with a radius of 1500 μm centred on the fovea) with or without pigment A MAIA static threshold sensitivity < 25 dB at any point, within a customised grid, as measured using a MAIA device), at the same location of the 1 eye on 2 separate occasions Pupil dilation of ≥ 5 mm in each eye Fundus photographs, OCT and FAF images of adequate quality as assessed by the LEAD Image Reading Centre Ability and willingness to consent, and be randomised, to the 2RT active or sham laser treatment, and all qualification and follow‐up phases of the study
Exclusion criteria:
Any evidence of definite geographic atrophy within the macula (a circle with a radius of 3000 μm centred on the fovea). Geographic atrophy is defined as an area of partial or complete depigmentation of the RPE in the fundus photographs that has at least 2 of the following 3 characteristics: roughly round or oval shape, sharp margins and visibility of underlying large choroidal vessels. Any black (hypofluorescent) area of FAF consistent with GA (roughly round or oval shape, sharp margins), and corroborated on colour photography as a patch of hypopigmentation Any evidence of 'preclinical atrophy' as determined on OCT: loss of the outer retina (RPE and photoreceptors on the cube scan (Spectralis OCT) (49 horizontal B scans, 120 µm apart over a 20 x 20 degree scan). This covers approximately 6 x 6 mm in an emmetropic eye (note: peri‐papillary atrophy further than 1500 μm from the fovea is allowed) Current CNV, or past evidence of CNV in either eye. Any other experimental treatment for AMD, excluding dietary supplements, received in the past 12 months or thought likely to chronically change the course of the participant's retinal disease Any OCT showing evidence of intraretinal fluid, or subretinal fluid for which CNV cannot be excluded as a cause A subfoveal pigment epithelial detachment/drusenoid detachment > 1000 μm in diameter Other macular disease with subretinal deposits not typical of AMD, e.g. Malattia Leventinese, Sorsby fundus dystrophy and Alport's syndrome Ocular disease in either eye, other than AMD, which significantly compromises the ability to treat or visualise the fundus or would compromise the ability to assess any effect following laser application including; diabetic retinopathy (unless limited to < 10 microaneurysms or small retinal haemorrhages, or both, without retinal thickening on OCT), angioid streaks, central serous choroidopathy, optic atrophy, epiretinal membrane involving the macula, pigmentary abnormalities of the retina atypical of AMD (e.g. myopia, pattern dystrophy or chronic central serous retinopathy), myopic crescent wider than 50% of the longest diameter of the optic disc, or closer than 1500 μm to the fovea, macular hole or pseudohole, retinal vein occlusion, active uveitis, presumed ocular histoplasmosis syndrome, choroidal naevus within 2 DD of the fovea associated with depigmentation or overlying drusen, if these drusen are used to determine eligibility. Amblyopia in either eye even if BCVA is better than 6/12 (20/40) Known allergic hypersensitivity to fluorescein Previous retinal or other ocular surgical procedures, the effects of which may now or in the future complicate assessment of the progression of AMD Requirement for any systemic or ocular medication known to be toxic to the retina, such as: deferoxamine, chloroquine/hydroxychloroquine (Plaquinil), chlorpromazine, phenothiazines and ethambutol Any serious systemic disease that will preclude a 3‐year survival and regular attendance for follow‐up Sensitivity to contact lens application Any condition that would make adherence to the examination schedule for 3 years difficult or unlikely Any history of prior laser surgery to the retina Intraocular pressures of 26 mm Hg or higher or if there is some reason to believe the participant may have glaucoma (e.g. demonstrated field defect typical of glaucoma, history of medical, surgical or laser intervention for the treatment of glaucoma, or disc/nerve fibre layer defects suggestive of glaucoma) Significant cataract: nuclear cataract grade 2 or 3, cortical cataract Grade 2 or 3 or posterior subcapsular cataract Grade 2 or 3, by Simplified Cataract Grading System (WHO Cataract Grading Group)
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| Outcomes |
Primary outcomes:
progression to advanced AMD in the treated eye (time frame: 36 months) rate of progression to advanced AMD, either CNV, geographic atrophy or preclinical atrophy, in the study eye of treatment group compared to the sham procedure group
Secondary outcomes:
progression to advanced AMD in the untreated eye (time frame: 36 months), rate of progression to advanced AMD, CNV, GA or preclinical atrophy in the fellow (untreated) eye
Other outcomes: reversal of early clinical indicators of AMD (time frame: 36 months), reversal of early clinical indicators of AMD (drusen area)
Improvements in visual acuity (time frame: 36 months) |
