Micropulse Laser for Geographic Atrophy

Institut de la Macula y la Retina11 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Geographic Atrophy Age-related Macular Degeneration

Interventions

MicropulsePROCEDURE

Between 1 and 3 sessions of micropulse laser will be applied in the inferior hemiretina of the randomly selected eye

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut de la màcula i de la retina

Barcelona, Spain

Outcomes

Primary Outcomes

Change in area of atrophy as measured with fundus autofluorescence (FAF)

Difference in baseline area of atrophy as measured with FAF at week 48

Time frame: Change in area from baseline to week 48

Data from ClinicalTrials.gov

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