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

Age-Related Macular Degeneration Clinical Trial

— SAVE  

Official title:

Focal Subthreshold Laser Treatment for Macular Drusen

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02960828
• Other study ID #: B-1508/312-004
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Retinal Drusen

Intervention

Procedure:
• Subthreshold Laser Photocoagulation
Selective Subthreshold Laser Photocoagulation is applied to the periphery of high-risk macular drusen

Drug:
• intravitreal Anti-VEGF injection
To prevent choroidal neovascularization, intravitreal Anti-VEGF injection is done on a 3 month interval up to 1 year.

Device:
• Subthreshold Laser

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyunggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in drusen size		3 month interval
Secondary	Best Corrected Visual Acuity (BCVA)	ETDRS and Snellen visual acuity measurement	3 months interval
Secondary	Change in drusen distribution		3 month interval
Secondary	Change in autofluorescence		3 month interval
Secondary	Choroidal Neovascularization		3 months interval
Secondary	Contrast Sensitivity	Contrast Sensitivity Test	3 months interval