Micropulse Laser for Geographic Atrophy

NCT01799564 | Completed

• 1 other identifier: MPL4DRY
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Geographic Atrophy; Age-related Macular Degeneration

Keywords

Geographic atrophy; Age-related macular degeneration; Fundus autofluorescence

Outcome Measures

Primary Outcomes (1)

• Change in area of atrophy as measured with fundus autofluorescence (FAF)

  Difference in baseline area of atrophy as measured with FAF at week 48

  Change in area from baseline to week 48

Study Arms (2)

Micropulse

EXPERIMENTAL

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

Control

NO INTERVENTION

The fellow eye does not receive any treatment

Interventions

Micropulse PROCEDURE

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

Micropulse

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GA \> 0.5 disk areas secondary to AMD in both eyes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de la Macula y la Retina: lead

Study Sites (1)

Institut de la màcula i de la retina

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jordi Monés, MD, PhD

  Institut de la màcula i de la retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 27, 2013
• Study Start: August 1, 2012
• Primary Completion: November 27, 2013
• Study Completion: November 27, 2013
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

ES (1)