NCT02569892

Brief Summary

This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 19, 2021

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

3.4 years

First QC Date

October 5, 2015

Results QC Date

March 9, 2021

Last Update Submit

October 13, 2021

Conditions

Macular DegenerationRetinal Drusen

Outcome Measures

Primary Outcomes (1)

  • Change in Macular Drusen Volume

    Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)

    baseline, 6, 12, and 24 months

Secondary Outcomes (2)

  • Change in Visual Acuity

    baseline, 6, 12, and 24 months

  • Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)

    2 years

Study Arms (2)

Laser Arm

EXPERIMENTAL

Participants receive treatment with sub-threshold macular laser photocoagulation

Device: Pascal Retinal Laser Photocoagulator

Sham Laser Arm

SHAM COMPARATOR

Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)

Device: Pascal Retinal Laser Photocoagulator

Interventions

Pascal Retinal Laser PhotocoagulatorDEVICE

Sub-threshold macular laser treatment with Pascal laser Endpoint Management System

Laser ArmSham Laser Arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 60 years of age.
  • Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle
  • Adequate pupil dilatation and 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 signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
  • Previous macular laser treatment.
  • Any previous ocular condition that may be associated with a risk of developing macular oedema.
  • Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).
  • Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
  • Important known allergies to sodium fluorescein dye used in angiography.
  • Ocular or periocular infections.
  • Planned intra-ocular surgery within one year.
  • Patient is unavailable for follow-up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Macular DegenerationRetinal Drusen

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Limitations and Caveats

This study did not meet enrollment goal of 60 study eyes.

Results Point of Contact

Title
Steven Sanislo, MD
Organization
Stanford University School of Medicine
ssanislo@stanford.edu
650-723-6995

Study Officials

  • Steven Sanislo, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 7, 2015

Study Start

September 1, 2016

Primary Completion

February 1, 2020

Study Completion

January 25, 2021

Last Updated

October 28, 2021

Results First Posted

May 19, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)