Micropulse Laser for Geographic Atrophy

Not Applicable

Completed

• Conditions: Geographic Atrophy; Age-related Macular Degeneration
• Interventions: Procedure: Micropulse

• Registration Number: NCT01799564
• Lead Sponsor: Institut de la Macula y la Retina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-02-25
• Study First Posted: 2013-02-27
• Primary Completion: 2013-11-27
• Study Completion: 2013-11-27
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micropulse	Micropulse	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

Primary Outcome Measures

Name	Time	Method
Change in area of atrophy as measured with fundus autofluorescence (FAF)	Change in area from baseline to week 48	Difference in baseline area of atrophy as measured with FAF at week 48

Trial Locations

Locations (1)

Institut de la màcula i de la retina; 🇪🇸 Barcelona, Spain