None listed
Conditions
Interventions
None listed
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for the Nonexudative Age-Related Macular Degeneration (ASIANO Arm) 1. Korean individuals aged between 50 and 80 years at the time of screening. 2. Diagnosed within the past year at the time of screening as follows: Arm 1) Bilateral intermediate age-related macular degeneration. Arm 2): Presence of at least one of the following findings in one or both eyes: a) Drusen-like deposition (DLD) – DLD with retinal pigment epithelium (RPE) elevation (undulation) on spectral-domain optical coherence tomography (SD-OCT). b) Focal area of tortuous and dilated inner choroidal vessels – Lesion visible on fundus examination, with RPE elevation (undulation) on SD-OCT. c) Retinal pigmentary changes – Observed on fundus examination or showing focal irregular fluorescence on fundus autofluorescence imaging, with RPE elevation (undulation) or RPE disruption on SD-OCT. 3. Neither eye meets the criteria for advanced AMD. 4. Clear ocular media and availability of high-quality color fundus photography allowing distinct visualization of macular lesions. 5. Willingness to return for annual follow-up evaluations over a period of at least 5 years. 6. Provided written informed consent after sufficient explanation of the study. Inclusion Criteria for the Exudative Age-Related Macular Degeneration (KEATS Arm) 1. Korean individuals aged between 50 and 80 years at the time of screening. 2. Newly diagnosed exudative AMD in at least one eye, including: Choroidal neovascularization (CNV), Polypoidal choroidal vasculopathy (PCV), Retinal angiomatous proliferation (RAP) diagnosed based on spectral-domain OCT, fluorescein angiography (FA), and indocyanine green angiography (ICGA). 3. Clear ocular media and availability of high-quality color fundus photography allowing distinct visualization of macular lesions. 4. Willingness to return for annual follow-up evaluations over a period of at least 5 years. 5. Provided written informed consent after sufficient explanation of the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for the Nonexudative Age-Related Macular Degeneration (ASIANO Arm) 1. Presence of other vitreoretinal or macular diseases causing structural damage to the macula, aside from intermediate AMD. This includes: Advanced AMD, Diabetic retinopathy of moderate nonproliferative stage (NPDR) or worse, Epiretinal membrane affecting vision, Optic atrophy, Pathologic myopia, Macular hole, Retinal vascular diseases, Choroidal nevus, Uveitis, Amblyopia, Choroidal neovascularization from causes other than AMD 2. High myopia defined as spherical equivalent worse than –6.5 diopters or axial length = 26.5 mm 3. Media opacity preventing acquisition of clear fundus imaging 4. History of any intraocular surgery other than cataract extraction that may affect AMD progression (e.g., vitrectomy) 5. History of macular laser therapy, photodynamic therapy, or intravitreal anti-VEGF treatment 6. Systemic or ocular diseases requiring long-term administration of medications potentially toxic to the retina or optic nerve 7. Intraocular pressure >26 mmHg, or history or likelihood of requiring glaucoma filtering surgery 8. Inability to commit to at least 5 years of annual follow-up 9. History of systemic anti-angiogenic therapy (e.g., for malignancy) or prior intraocular anti-angiogenic treatment in the study eye 10. Known allergy to fluorescein or indocyanine green dye Exclusion Criteria for the Exudative Age-Related Macular Degeneration (KEATS Arm) 1. Presence of other vitreoretinal or macular diseases causing structural damage to the macula, aside from intermediate AMD. This includes: Advanced AMD, Diabetic retinopathy of moderate nonproliferative stage (NPDR) or worse, Active central serous chorioretinopathy, Epiretinal membrane affecting vision, Optic atrophy, Pathologic myopia, Macular hole, Retinal vascular diseases, Choroidal nevus, Uveitis, Amblyopia, Choroidal neovascularization from causes other than AMD 2. High myopia defined as spherical equivalent worse than –6.5 diopters or axial length = 26.5 mm 3. Media opacity preventing acquisition of clear fundus imaging 4. History of any intraocular surgery other than cataract extraction that may affect AMD progression (e.g., vitrectomy) 5. Systemic or ocular diseases requiring long-term administration of medications potentially toxic to the retina or optic nerve 6. Intraocular pressure >26 mmHg, or history or likelihood of requiring glaucoma filtering surgery 7. Inability to commit to at least 5 years of annual follow-up 8. History of systemic anti-vascular endothelial growth factor (anti-VEGF) therapy (e.g., for malignancy) or prior intraocular anti-VEGF treatment in the study eye 9. Known allergy to fluorescein or indocyanine green dye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASIANO ARM - Progression to advanced age-related macular degeneration (exudative age-related macular degeneration, geographic atrophy);KEATS ARM - Five-year changes in best-corrected visual acuity after treatment for exudative age-related macular degeneration | — |
Secondary
| Measure | Time frame |
|---|---|
| KEATS ARM - Progression to advanced AMD age-related macular degeneration (both exudative and nonexudative) in the fellow eye;KEATS ARM - Number and frequency of anti-vascular endothelial growth factor (anti-VEGF) monotherapy treatments | — |
Countries
Korea, Republic of
Contacts
Public ContactSungsoon Hwang
Samsung Medical Center
Outcome results
None listed