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

NCT ID: NCT02569892

Last Updated: 2021-10-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2021-01-25

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Degeneration Retinal Drusen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laser Arm

Participants receive treatment with sub-threshold macular laser photocoagulation

Group Type EXPERIMENTAL

Pascal Retinal Laser Photocoagulator

Intervention Type DEVICE

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

Sham Laser Arm

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

Group Type SHAM_COMPARATOR

Pascal Retinal Laser Photocoagulator

Intervention Type DEVICE

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

Interventions

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Pascal Retinal Laser Photocoagulator

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bascom Palmer Eye Institute

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Steven R. Sanislo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Sanislo, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Byers Eye Institute at Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-33991

Identifier Type: -

Identifier Source: org_study_id