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

Not Applicable

• Conditions: Age-Related Macular Degeneration; Retinal Drusen
• Interventions: Procedure: Subthreshold Laser Photocoagulation; Drug: intravitreal Anti-VEGF injection; Device: Subthreshold Laser

• Registration Number: NCT02960828
• Lead Sponsor: Seoul National University Bundang Hospital

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)

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-19
• Primary Completion: 2020-05
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention-"Device:_Laser"	Subthreshold Laser Photocoagulation	* Subthreshold focal photocoagulation * Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection
Intervention-"Device:_Laser"	intravitreal Anti-VEGF injection	* Subthreshold focal photocoagulation * Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection
Intervention-"Device:_Laser"	Subthreshold Laser	* Subthreshold focal photocoagulation * Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection

Primary Outcome Measures

Name	Time	Method
Change in drusen size	3 month interval

Secondary Outcome Measures

Name	Time	Method
Change in drusen distribution	3 month interval
Best Corrected Visual Acuity (BCVA)	3 months interval	ETDRS and Snellen visual acuity measurement
Change in autofluorescence	3 month interval
Choroidal Neovascularization	3 months interval
Contrast Sensitivity	3 months interval	Contrast Sensitivity Test

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyunggi-do, Korea, Republic of