"Stop Early Age-related Macular Degeneration (AMD) From Vision Loss Eternally" Study (SAVE)

Seoul National University

Status: Unknown

Conditions: Age-Related Macular Degeneration; Retinal Drusen

Treatments: Procedure: Subthreshold Laser Photocoagulation; Drug: intravitreal Anti-VEGF injection; Device: Subthreshold Laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02960828

B-1508/312-004

Details and patient eligibility

About

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.

Full description

SAVE Study (Stop Early Age-related Macular Degeneration form Vision Loss Eternally)

Enrollment: 21 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Intervention-"Device:_Laser"

Experimental group

Description:

* Subthreshold focal photocoagulation * Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection

Treatment:

Device: Subthreshold Laser

Drug: intravitreal Anti-VEGF injection

Procedure: Subthreshold Laser Photocoagulation

Control

No Intervention group

Description:

Contralateral eye