Micropulse Laser for Geographic Atrophy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01799564

Acronym

MPL4DRY

Enrollment

Registered

2013-02-27

Start date

2012-08-31

Completion date

2013-11-27

Last updated

2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration, Geographic Atrophy

Keywords

Geographic atrophy, Age-related macular degeneration, Fundus autofluorescence

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.

Interventions

PROCEDUREMicropulse

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026