- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799564
Micropulse Laser for Geographic Atrophy (MPL4DRY)
September 16, 2019 updated by: Jordi Mones MD PhD, Institut de la Macula y la Retina
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Barcelona, Spain, 08022
- Institut de la Macula i de la Retina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in area of atrophy as measured with fundus autofluorescence (FAF)
Time Frame: Change in area from baseline to week 48
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Difference in baseline area of atrophy as measured with FAF at week 48
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Change in area from baseline to week 48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jordi Monés, MD, PhD, Institut de la Macula i de la Retina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
November 27, 2013
Study Completion (Actual)
November 27, 2013
Study Registration Dates
First Submitted
February 25, 2013
First Submitted That Met QC Criteria
February 25, 2013
First Posted (Estimate)
February 27, 2013
Study Record Updates
Last Update Posted (Actual)
September 18, 2019
Last Update Submitted That Met QC Criteria
September 16, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPL4DRY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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