Age-Related Macular Degeneration, Retinal Drusen
Conditions
Brief summary
This study aims to validate the efficacy and safety of subthreshold laser photocoagulation on high-risk macular drusen in early age-related macular degeneration which has a high risk of conversion to exudative AMD.
Detailed description
SAVE Study (Stop Early Age-related Macular Degeneration form Vision Loss Eternally)
Interventions
PROCEDURESubthreshold Laser Photocoagulation
Selective Subthreshold Laser Photocoagulation is applied to the periphery of high-risk macular drusen
To prevent choroidal neovascularization, intravitreal Anti-VEGF injection is done on a 3 month interval up to 1 year.
DEVICESubthreshold Laser
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Drusen in both eyes examined under fundoscopy * At least one of the eyes must have high-risk soft drusen * BCVA below ETDRS 83 letters * Patient with consent to participate
Exclusion criteria
* Prior diagnosis with choroidal neovascularization * Exudative AMD in at least one eye * If the patient has only one visually effective eye (last eye) * Other macula or retinal diseases than age-related macular degeneration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in drusen size | 3 month interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | 3 months interval | ETDRS and Snellen visual acuity measurement |
| Change in drusen distribution | 3 month interval | — |
| Change in autofluorescence | 3 month interval | — |
| Choroidal Neovascularization | 3 months interval | — |
| Contrast Sensitivity | 3 months interval | Contrast Sensitivity Test |
Countries
South Korea
Outcome results
None listed