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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569892
Recruitment Status : Completed
First Posted : October 7, 2015
Results First Posted : May 19, 2021
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
Bascom Palmer Eye Institute
Information provided by (Responsible Party):
Steven R. Sanislo, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Retinal Drusen Device: Pascal Retinal Laser Photocoagulator Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : January 25, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Laser Arm
Participants receive treatment with sub-threshold macular laser photocoagulation
 Device: Pascal Retinal Laser Photocoagulator
Sub-threshold macular laser treatment with Pascal laser Endpoint Management System
Sham Comparator: Sham Laser Arm
Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)
 Device: Pascal Retinal Laser Photocoagulator
Sub-threshold macular laser treatment with Pascal laser Endpoint Management System


Outcome Measures
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Primary Outcome Measures :
  1. Change in Macular Drusen Volume [ Time Frame: baseline, 6, 12, and 24 months ]
    Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)


Secondary Outcome Measures :
  1. Change in Visual Acuity [ Time Frame: baseline, 6, 12, and 24 months ]
    Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart

  2. Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV) [ Time Frame: 2 years ]
    Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569892


Locations
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United States, California
Byers Eye Institute at Stanford University
Palo Alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
Bascom Palmer Eye Institute
Investigators
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Principal Investigator: Steven Sanislo, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Steven R. Sanislo, Stanford University:
Study Protocol and Statistical Analysis Plan  [PDF] August 15, 2018

More Information
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Responsible Party: Steven R. Sanislo, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02569892    
Other Study ID Numbers: IRB-33991
First Posted: October 7, 2015    Key Record Dates
Results First Posted: May 19, 2021
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Drusen
Retinal Degeneration
Retinal Diseases
Eye Diseases