NCT03968575

Brief Summary

To investigate the efficacy and safety of sub-threshold micro-pulse laser therapy for drusen of dry age-related macular degeneration (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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

May 22, 2019

Last Update Submit

February 23, 2021

Conditions

Drusen

Outcome Measures

Primary Outcomes (2)

  • Change in macular drusen volume

    Mean change in macular drusen volume on optical coherence tomograph(OCT)

    6 and 12 months

  • Change in macular drusen area

    Mean change in macular drusen area on OCT

    6 and 12 months

Secondary Outcomes (1)

  • Change in visual acuity

    6 and 12 months

Study Arms (1)

Laser

EXPERIMENTAL
Device: laser treatment

Interventions

laser treatmentDEVICE

sub-threshold micro-pulse laser treatment

Laser

Eligibility Criteria

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

You may qualify if:

  • Older than 50 years of age.
  • Male or female patients with nonexudative AMD with a drusen diameter of at least 125um in the central 3mm circle
  • clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
  • Able to give an informed consent.

You may not qualify if:

  • Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
  • unclear media that no clear colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT can performed.
  • Ocular or periocular infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The eye of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Ying Huang

CONTACT

0577-88068855wzhuangying@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 30, 2019

Study Start

April 1, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2022

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

CN(1)