Age-related macular degeneration - intermediate AMD and geographic atrophy Eye Diseases
Conditions
Interventions
This is a prospective, observational study in two cohorts of participants with intermediate age-related macular degeneration (iAMD) or geographic atrophy (GA) in one or both eyes. It aims to recruit 2
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria – intermidiate AMD 1. Subjects of either sex aged 50 – 90 years old 2. Diagnosis of iAMD (defined by Beckmann Classification) at least in one eye 3. Visual acuity of Snellen 6/18 or better in at least one eye with media clarity, pupillary dilation, and subject cooperation sufficient for adequate imaging and functional tests Inclusion Criteria – GA 1. Subjects of either sex aged 50 – 90 years old 2. Diagnosis of hypoautofluorecence in at least one eye, either foveal or extrafoveal in location 3. Media clarity, pupillary dilation
Exclusion criteria
Exclusion criteria: The following exclusions apply to the study eye: 1. Co-existent ocular disease: Any other ocular condition that, in the opinion of the investigator, might affect or alter the visual acuity, for example, amblyopia. 2. A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (eg. a cataract would be reducing acuity to 6/12 or worse if the eye was otherwise normal). 3. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within the prior 3 months or anticipated within the next 6 months following enrolment. 4. Concurrent or history of retinal laser photocoagulation or anti-vascular endothelial growth factor (anti-VEGF) treatment for exudative MNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy 5. Previous participation in interventional clinical trials for GA or early stages of AMD, except for vitamins and minerals, regardless of the route
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. For intermediate age-related macular degeneration (iAMD) group, time to conversion from iAMD to nGA/iRORA/cRORA/ hypoautofluorescense evidence of GA measured using imaging modalities below from baseline up to 1 year 2. Conversion from nGA/iRORA to cRORA/GA measured using imaging modalities below from baseline up to 1 year 3. For GA, change from baseline in disease progression measured using imaging modalities below from baseline up to 1 year Imaging modalities: Spectral domain optical coherence tomography (SD-OCT), OCT angiography (OCTA), near-infrared reflectance (NIR), fundus autofluorescence (FAF), colour photographs and FAF and Enhanced depth imaging OCT (EDI-OCT), dark adaptation (DA) for rod intercept time (RIT) and microperimetry (MP). Abbreviations: nGA: Nascent geographic atrophy, iRORA: incomplete retinal pigment epithelium and outer retinal atrophy, cRORA: complete retinal pigment epithelium and outer retinal atrophy, GA - geographic atrophy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in choroidal thickness at 3, 6 and 12 months. 2. Change from baseline in choroidal choriocapillaris flow deficits at 3, 6 and 12 months. 3. Slope of change from baseline in square root transformed GA lesion area 4. Change from iRORA to nGA and relation to functional parameters. 5. Change from baseline in area and linear measure of EZ/ELM/RPE loss at 3, 6 and 12 months. 6. Change from baseline in mean and point to point retinal sensitivity on microperimetry at 3, 6 and 12 months. 7. Change from baseline in Rod intercept time in minutes at 12 months 8. Change from baseline in Low Luminance Deficit at 3, 6 and 12 months 9. Change from baseline in drusen volume measured as RPE-BM thickness at 3, 6 and 12 months 10. Difference in choroidal flow metrics in eyes with subretinal drusenoid deposits (SDD) versus those without SDD. Imaging modalities: Spectral domain optical coherence tomography (SD-OCT), OCT angiography (OCTA), near-infrared reflectance (NIR), fundus autofluorescence (FAF), colour photographs and FAF and Enhanced depth imaging OCT (EDI-OCT), dark adaptation (DA) for rod intercept time (RIT) and microperimetry (MP). Abbreviations: EZ- ellipsoid zone, ELM - External limiting membrane, RPE - retinal pigment epithelium, SDD : subretinal drusenoid deposits, RPE-BM: Retinal pigment epithelium - Bruchs membrane. | — |
Countries
England, United Kingdom
Contacts
Public ContactRabiah Abbas Saud
Outcome results
None listed