Age related macular degeneration Eye Diseases Degeneration of macula and posterior pole
Conditions
Interventions
Training on the Ellex 2RTTM will be provided by Ellex Australia and Ellex Services Europe in advance of the trial start date.
Set-up: The patient will have local anaesthetic drops and guttae tropicam
Sponsors
London Eye Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age-Related Eye Disease Study (AREDS) simplified severity scale for AMD score of 2 or more 2. Bilateral drusen >125µm and pigmentary abnormalities (AREDS simplified severity risk score 4) 3. Pigmentary abnormalities in both eyes (AREDS simplified severity risk score 2) 4. Intermediate drusen (63 µm) in both eyes and at least one eye with pigment abnormalities (AREDS simplified severity risk score 2) 5. A combination of pigment abnormalities and large drusen >125µm (either eye; AREDS simplified severity risk score 2) 6. At least one eye with neovascular AMD (AREDS simplified severity risk score 2) 7. At least one eye with geographic atrophy (GA) 8. Male and female, age>50
Exclusion criteria
Exclusion criteria: 1. Ocular disease in either eye, other than AMD, that compromises the ability to treat or visualize the fundus or would compromise the ability to assess any effect following laser application, including: 1.1. Diabetic retinopathy unless retinopathy is limited to fewer than 10 microaneurysms and/or small retinal haemorrhages and without thickening on optical coherence tomography (OCT) 1.2. Uncontrolled glaucoma; a significant glaucomatous change (optic cup-disc ratio >0.7; intraocular pressure (IOP) >26mmHg on 2 or more occasions in at least one eye) ? ocular anti-hypertensive treatment is permitted as long as IOP is well-controlled with no field loss encroaching onto the macula 1.3. Other retinal diseases such as angioid streaks, central serous retinopathy 1.4. Epiretinal membrane of significant size located in the macular area 1.5. Optic atrophy 1.6. Pigmentary abnormalities used to qualify for inclusion that are not typical of AMD (such as myopia, pattern dystrophy or central serous retinopathy 1.7. Moderate myopia (5D) where the fundus presents as a typical myopic fundus with a myopic crescent at the disc with width =50% of the longest diameter of the disc. 1.8. Macular hole or pseudohole 1.9. Retinal vein occlusion, active uveitis, presumed ocular histoplasmosis syndrome, other sight-threatening retinopathies and retinal degeneration. Significant explained or unexplained visual loss. 1.10. A choroidal naevus within 2 DD of the centre of the macula associated with depigmentation or overlying atypical drusen 2. Other ocular diseases or conditions, the presence of which may now or in the future complicate evaluation of AMD Amblyopia (mild amblyopia without significant VA loss can be included) 3. Chronic requirement for any systemic or ocular medication administered for other diseases and known to be toxic to the retina or optic nerve, such as: 3.1. Desferioxamine 3.2. Chloroquine/hydroxycholoroquine 3.3. Chorpromazine 3.4. Phenothiazines 3.5. Chronic systemic steroid use of at least 10mg per day or more 3.6. Ethambutol 4. Significant cataract 5. Nuclear cataract grade 2 or 3; cortical cataract grade 2 or 3; posterior subcapsular cataract grade 2 or 3 (using simplified cataract grading system for international epidemiological studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Loss of <10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters 2. ETDRS best corrected visual acuity in the intervention eye at 3 months (based on published coefficient of repeatability 95% for ETDRS acuity in intermediate to high-risk Early AMD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant (p<0.05) improvement in sensitivity in 3 or more test areas on MaiaTM microperimetry testing at 3 months. | — |
Countries
United Kingdom
Outcome results
None listed