"Stop Early Age-related Macular Degeneration (AMD) From V... | NCT02960828

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

NCT02960828

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Sep 19, 2019Actual

Enrollment

21Estimated

Phase

Not Applicable

Conditions

Age-Related Macular Degeneration
Retinal Drusen

Interventions

Subthreshold Laser Photocoagulation
intravitreal Anti-VEGF injection
Subthreshold Laser

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

May 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 30, 2016

First Submission Date that Met QC Criteria

Nov 9, 2016

First Posted Date

Nov 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2019

Last Update Posted Date

Sep 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kyu Hyung Park, Professor, Chief of department of Ophthalmology, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention-"Device:_Laser"	Experimental	Subthreshold focal photocoagulation Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection	Procedure: Subthreshold Laser Photocoagulation Drug: intravitreal Anti-VEGF injection Device: Subthreshold Laser
Control	No Intervention	Contralateral eye

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subthreshold Laser Photocoagulation	Procedure	Selective Subthreshold Laser Photocoagulation is applied to the periphery of high-risk macular drusen	Intervention-"Device:_Laser"

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in drusen size		3 month interval

Secondary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity (BCVA)	ETDRS and Snellen visual acuity measurement	3 months interval
Change in drusen distribution		3 month interval

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyu Hyung Park, M.D., Ph.D.	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam	Gyunggi-do	463-707	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D015593	Retinal Drusen

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided