Back to results"Stop Early Age-related Macular Degeneration (AMD) From Vision Loss Eternally" Study (SAVE)
Primary Purpose
Age-Related Macular Degeneration, Retinal Drusen
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Subthreshold Laser Photocoagulation
intravitreal Anti-VEGF injection
Subthreshold Laser
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention-"Device:_Laser"
Control
Arm Description
Subthreshold focal photocoagulation Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection
Contralateral eye
Outcomes
Primary Outcome Measures
Change in drusen size
Secondary Outcome Measures
Best Corrected Visual Acuity (BCVA)
ETDRS and Snellen visual acuity measurement
Change in drusen distribution
Change in autofluorescence
Choroidal Neovascularization
Contrast Sensitivity
Contrast Sensitivity Test
Full Information
NCT ID
NCT02960828
First Posted
June 30, 2016
Last Updated
September 18, 2019
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02960828
Brief Title
"Stop Early Age-related Macular Degeneration (AMD) From Vision Loss Eternally" Study
Acronym
SAVE
Official Title
Focal Subthreshold Laser Treatment for Macular Drusen
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Retinal Drusen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention-"Device:_Laser"
Arm Type
Experimental
Arm Description
Subthreshold focal photocoagulation
Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection
Arm Title
Control
Arm Type
No Intervention
Arm Description
Contralateral eye
Intervention Type
Procedure
Intervention Name(s)
Subthreshold Laser Photocoagulation
Intervention Description
Selective Subthreshold Laser Photocoagulation is applied to the periphery of high-risk macular drusen
Intervention Type
Drug
Intervention Name(s)
intravitreal Anti-VEGF injection
Intervention Description
To prevent choroidal neovascularization, intravitreal Anti-VEGF injection is done on a 3 month interval up to 1 year.
Intervention Type
Device
Intervention Name(s)
Subthreshold Laser
Primary Outcome Measure Information:
Title
Change in drusen size
Time Frame
3 month interval
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity (BCVA)
Description
ETDRS and Snellen visual acuity measurement
Time Frame
3 months interval
Title
Change in drusen distribution
Time Frame
3 month interval
Title
Change in autofluorescence
Time Frame
3 month interval
Title
Choroidal Neovascularization
Time Frame
3 months interval
Title
Contrast Sensitivity
Description
Contrast Sensitivity Test
Time Frame
3 months interval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Hyung Park, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyunggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided
Learn more about this trial
"Stop Early Age-related Macular Degeneration (AMD) From Vision Loss Eternally" Study
We'll reach out to this number within 24 hrs