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

September 18, 2019 updated by: Kyu Hyung Park, Seoul National University Bundang Hospital

Focal Subthreshold Laser Treatment for Macular Drusen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyunggi-do
      • Seongnam, Gyunggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention-"Device:_Laser"
  • Subthreshold focal photocoagulation
  • Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection
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
No Intervention: Control
Contralateral eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in drusen size
Time Frame: 3 month interval
3 month interval

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Kyu Hyung Park, M.D., Ph.D., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 10, 2016

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1508/312-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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