Micropulse Laser for Geographic Atrophy

Study Overview
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Brief Summary
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Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further vision loss.

Official Title
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A Phase I Study to Establish the Safety and Efficacy of Retinal Pigment Epithelium Micropulse Laser in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

Conditions
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Geographic Atrophy, Age-related Macular Degeneration

Intervention / Treatment
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* Procedure: Micropulse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GA > 0.5 disk areas secondary to AMD in both eyes 50 years or older The periphery of the atrophic lesions must demonstrate increased autofluorescence Best corrected visual acuity between 20/20 and 20/400 inclusive Clear ocular media Ability to provide informed consent and attend all study visits Exclusion Criteria: GA secondary to other causes aside from AMD Evidence of choroidal neovascularization in either eye Any prior treatment for AMD, aside from antioxidants Any other ocular condition that would progress in the study period and confound visual acuity assessment Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve Presence of idiopathic or autoimmune-associated uveitis Any intraocular surgery 3 months of entry Any prior thermal laser in the macula History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery Previous therapeutic radiation in the ocular region in either eye Any treatment with an investigational agent in the previous 60 days before study entry

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micropulse<br>Micropulse laser will be applied to the inferior hemiretina next to the area of atrophy in a randomly selected eye in 1, 2 or 3 occasions | Procedure: Micropulse<br>* Between 1 and 3 sessions of micropulse laser will be applied in the inferior hemiretina of the randomly selected eye<br>|
| No Intervention: Control<br>The fellow eye does not receive any treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in area of atrophy as measured with fundus autofluorescence (FAF) | Difference in baseline area of atrophy as measured with FAF at week 48 | Change in area from baseline to week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geographic atrophy, Age-related macular degeneration, Fundus autofluorescence