Micropulse Laser for Geographic Atrophy

Age-related Macular Degeneration Clinical Trial

— MPL4DRY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799564
• Other study ID #: MPL4DRY
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: November 27, 2013

Study information

• Verified date: September 2019
• Source: Institut de la Macula y la Retina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 27, 2013
• Est. primary completion date: November 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Spain	Institut de la màcula i de la retina	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut de la Macula y la Retina

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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