Micropulse Laser for Geographic Atrophy

NCT01799564 — Not applicable, Completed, 11 participants, Institut de la Macula y la Retina

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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

Registry	NCT01799564, acronym MPL4DRY
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	11 (Actual)
Sponsor	Institut de la Macula y la Retina (Other)
Conditions	Geographic Atrophy, Age-related Macular Degeneration
Interventions	Micropulse (Procedure)
Dates	start 2012-08-01, primary completion 2013-11-27, completion 2013-11-27, first posted 2013-02-27, last updated 2019-09-18
Locations	1 site in Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Micropulse	Experimental	Procedure: 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
Control	No intervention		The fellow eye does not receive any treatment

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 50 Years to any

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)

Facility	City	Country	Status
Institut de la màcula i de la retina	Barcelona	Spain

+Investigators

Jordi Monés, MD, PhD, Principal investigator, Institut de la màcula i de la retina