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Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration

Primary Purpose

Macular Degeneration, Retinal Drusen

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pascal Retinal Laser Photocoagulator
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Older than 60 years of age.
  2. Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle
  3. Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
  4. Able to give an informed consent.

Exclusion Criteria:

  1. Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
  2. Previous macular laser treatment.
  3. Any previous ocular condition that may be associated with a risk of developing macular oedema.
  4. 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).
  5. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
  6. Important known allergies to sodium fluorescein dye used in angiography.
  7. Ocular or periocular infections.
  8. Planned intra-ocular surgery within one year.
  9. Patient is unavailable for follow-up visits.

Sites / Locations

  • Byers Eye Institute at Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser Arm

Sham Laser Arm

Arm Description

Participants receive treatment with sub-threshold macular laser photocoagulation

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Visual Acuity
Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart
Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)
Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.

Full Information

First Posted
October 5, 2015
Last Updated
October 13, 2021
Sponsor
Stanford University
Collaborators
Bascom Palmer Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02569892
Brief Title
Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
Official Title
Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
January 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Bascom Palmer Eye Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Retinal Drusen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Arm
Arm Type
Experimental
Arm Description
Participants receive treatment with sub-threshold macular laser photocoagulation
Arm Title
Sham Laser Arm
Arm Type
Sham Comparator
Arm Description
Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
Intervention Type
Device
Intervention Name(s)
Pascal Retinal Laser Photocoagulator
Intervention Description
Sub-threshold macular laser treatment with Pascal laser Endpoint Management System
Primary Outcome Measure Information:
Title
Change in Macular Drusen Volume
Description
Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)
Time Frame
baseline, 6, 12, and 24 months
Secondary Outcome Measure Information:
Title
Change in Visual Acuity
Description
Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart
Time Frame
baseline, 6, 12, and 24 months
Title
Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)
Description
Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Sanislo, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byers Eye Institute at Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration

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