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Micropulse Laser for Geographic Atrophy (MPL4DRY)

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ClinicalTrials.gov Identifier: NCT01799564
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jordi Mones MD PhD, Institut de la Macula y la Retina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Age-related Macular Degeneration Procedure: Micropulse Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2012
Actual Primary Completion Date : November 27, 2013
Actual Study Completion Date : November 27, 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Procedure: Micropulse
Between 1 and 3 sessions of micropulse laser will be applied in the inferior hemiretina of the randomly selected eye
No Intervention: Control
The fellow eye does not receive any treatment


Outcome Measures
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Primary Outcome Measures :
  1. Change in area of atrophy as measured with fundus autofluorescence (FAF) [ Time Frame: Change in area from baseline to week 48 ]
    Difference in baseline area of atrophy as measured with FAF at week 48


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799564


Locations
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Spain
Institut de la màcula i de la retina
Barcelona, Spain, 08022
Sponsors and Collaborators
Institut de la Macula y la Retina
Investigators
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Principal Investigator: Jordi Monés, MD, PhD Institut de la màcula i de la retina
More Information
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Responsible Party: Jordi Mones MD PhD, MD, PhD, Institut de la Macula y la Retina
ClinicalTrials.gov Identifier: NCT01799564    
Other Study ID Numbers: MPL4DRY
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Keywords provided by Jordi Mones MD PhD, Institut de la Macula y la Retina:
Geographic atrophy
Age-related macular degeneration
Fundus autofluorescence
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical