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Micropulse Laser for Geographic Atrophy (MPL4DRY)

Primary Purpose

Geographic Atrophy, Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Micropulse
Sponsored by
Institut de la Macula y la Retina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy focused on measuring Geographic atrophy, Age-related macular degeneration, Fundus autofluorescence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut de la màcula i de la retina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Micropulse

Control

Arm Description

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

The fellow eye does not receive any treatment

Outcomes

Primary Outcome Measures

Change in area of atrophy as measured with fundus autofluorescence (FAF)
Difference in baseline area of atrophy as measured with FAF at week 48

Secondary Outcome Measures

Full Information

First Posted
February 25, 2013
Last Updated
September 16, 2019
Sponsor
Institut de la Macula y la Retina
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1. Study Identification

Unique Protocol Identification Number
NCT01799564
Brief Title
Micropulse Laser for Geographic Atrophy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 27, 2013 (Actual)
Study Completion Date
November 27, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de la Macula y la Retina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy, Age-related Macular Degeneration
Keywords
Geographic atrophy, Age-related macular degeneration, Fundus autofluorescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micropulse
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
The fellow eye does not receive any treatment
Intervention Type
Procedure
Intervention Name(s)
Micropulse
Intervention Description
Between 1 and 3 sessions of micropulse laser will be applied in the inferior hemiretina of the randomly selected eye
Primary Outcome Measure Information:
Title
Change in area of atrophy as measured with fundus autofluorescence (FAF)
Description
Difference in baseline area of atrophy as measured with FAF at week 48
Time Frame
Change in area from baseline to week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi Monés, MD, PhD
Organizational Affiliation
Institut de la màcula i de la retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de la màcula i de la retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Micropulse Laser for Geographic Atrophy

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