Study protocol on prevalence of non-exudative macular neovascularisation and its contribution to prediction of exudation in fellow eyes with unilateral exudative AMD (EYE-NEON)

PURPOSE: Fellow eyes of patients with unilateral neovascular age-related macular degeneration (nAMD) are at risk of developing macular neovascularisation (MNV). These eyes may first develop subclinical non-exudative MNV (neMNV) before they leak to form exudative MNV (eMNV). The EYE NEON study is a 2-year study aimed at estimating the prevalence and incidence of neMNV and evaluating its role as a predictor for conversion to neovascular AMD. METHODS: EYE NEON is a multicentre study that will run in retinal clinics across 25 National Health Service with the aim to recruit 800 patients with new onset nAMD in the first eye. The fellow-eye with no evidence of nAMD at baseline will be the study eye. All study eyes will have OCT and OCTA done at first and second year following first anti-VEGF treatment to the first eye (non-study eye), with new onset nAMD. We will estimate the prevalence and incidence of neMNV over 2 years, rate of conversion from neMNV to eMNV and numbers initiated on treatment for neovascular AMD in the study eye will be reported. Predictive models of conversion including neMNV with other demographic and imaging parameters will be developed. CONCLUSION: The study design with proposed target sample size is sufficient to evaluate the retinal imaging characteristics of the study eyes with and without neMNV and develop predictive models to inform risk of conversion to nAMD

The double layer sign is highly predictive of progression to exudation in age-related macular degeneration

PURPOSEThe presence of a double layer sign (DLS) and a shallow irregular RPE elevation (SIRE) were investigated using spectral domain-optical coherence tomography (SD-OCT) imaging to determine their ability to predict progression to exudative macular neovascularization (eMNV) in the unaffected fellow eyes (study eye) of participants with Age-Related Macular Degeneration (AMD) with newly diagnosed unilateral eMNV. DESIGNRetrospective, re-analysis of SD-OCT scans of study eyes from the Early detection of Neovascular AMD (EDNA) study with 3 years follow-up (FU). PARTICIPANTSThe EDNA study repository of SD-OCT scans was assessed for inclusion. Cases with incomplete datasets, low quality scans or exhibiting other pathology were excluded, which resulted in 459 eligible cases. METHODSSD-OCT volume scans of study eyes were graded for irregular elevation of the RPE (IE), length and height measurements made on the most affected B-scan. Eyes with heterogeneous reflectivity within the IE were classified as exhibiting the DLS. Eyes with DLS where the length of separation between RPE and Bruch's was equal or exceeded 1000 μm in length and less than 100 μm in height were sub-classified as SIRE. MAIN OUTCOME MEASURESHazard of progression to eMNV for DLS and SIRE RESULTS: Of the 459 eyes, 268 had IE in which 101 were DLS-like and 51 of these also fulfilled criteria for SIRE. Over the 3 years FU period, 104 (23%) eyes progressed to eMNV. After a follow up of 18 months, a significantly higher proportion of study eyes (p<0.001) with IE, DLS and SIRE developed eMNV compared with those without these features (IE: 17% vs no IE 6.3%; DLS: 23% vs no DLS 9.9%; SIRE: 22% vs no SIRE 11%). In the adjusted Cox regression models, a significantly greater hazard of progression (p<0.001) was associated with the presence of IE (adjHR, 3.01, 95%CI 1.88, 4.82), DLS (adjHR, 3.41, 95%CI 2.26, 5.14) or SIRE (adjHR, 2.83, 95%CI 1.68, 4.75). CONCLUSIONThe DLS is a highly sensitive predictor of progression to eMNV and the use of SIRE does not improve predictability

Study protocol on prevalence of non-exudative macular neovascularisation and its contribution to prediction of exudation in fellow eyes with unilateral exudative AMD (EYE-NEON)

Abstract Purpose Fellow eyes of patients with unilateral neovascular age-related macular degeneration (nAMD) are at risk of developing macular neovascularisation (MNV). These eyes may first develop subclinical non-exudative MNV (neMNV) before they leak to form exudative MNV (eMNV). The EYE NEON study is a 2-year study aimed at estimating the prevalence and incidence of neMNV and evaluating its role as a predictor for conversion to neovascular AMD. Methods EYE NEON is a multicentre study that will run in retinal clinics across 25 National Health Service with the aim to recruit 800 patients with new onset nAMD in the first eye. The fellow-eye with no evidence of nAMD at baseline will be the study eye. All study eyes will have OCT and OCTA done at first and second year following first anti-VEGF treatment to the first eye (non-study eye), with new onset nAMD. We will estimate the prevalence and incidence of neMNV over 2 years, rate of conversion from neMNV to eMNV and numbers initiated on treatment for neovascular AMD in the study eye will be reported. Predictive models of conversion including neMNV with other demographic and imaging parameters will be developed. Conclusion The study design with proposed target sample size is sufficient to evaluate the retinal imaging characteristics of the study eyes with and without neMNV and develop predictive models to inform risk of conversion to nAMD. </jats:sec