NCT02960828

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

4.3 years

First QC Date

June 30, 2016

Last Update Submit

September 18, 2019

Conditions

Age-Related Macular DegenerationRetinal Drusen

Outcome Measures

Primary Outcomes (1)

  • Change in drusen size

    3 month interval

Secondary Outcomes (5)

  • Best Corrected Visual Acuity (BCVA)

    3 months interval

  • Change in drusen distribution

    3 month interval

  • Change in autofluorescence

    3 month interval

  • Choroidal Neovascularization

    3 months interval

  • Contrast Sensitivity

    3 months interval

Study Arms (2)

Intervention-"Device:_Laser"

EXPERIMENTAL

* Subthreshold focal photocoagulation * Intravitreal Anti-vascular endothelial growth factor (Anti-VEGF) injection

Procedure: Subthreshold Laser PhotocoagulationDrug: intravitreal Anti-VEGF injectionDevice: Subthreshold Laser

Control

NO INTERVENTION

Contralateral eye

Interventions

Subthreshold Laser PhotocoagulationPROCEDURE

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

Intervention-"Device:_Laser"
intravitreal Anti-VEGF injectionDRUG

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

Intervention-"Device:_Laser"
Subthreshold LaserDEVICE
Intervention-"Device:_Laser"

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyunggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Macular DegenerationRetinal Drusen

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Kyu Hyung Park, M.D., Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief of department of Ophthalmology

Study Record Dates

First Submitted

June 30, 2016

First Posted

November 10, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2020

Study Completion

December 1, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

KR(1)