Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration

Overview

This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2020

Interventions

  • Device: macular laser treatment
    • Sub-threshold macular laser treatment with Pascal laser Endpoint Management System
  • Device: sham macular laser treatment
    • Sham macular laser treatment with Pascal laser power setting of zero

Arms, Groups and Cohorts

  • Experimental: Laser Arm
    • Sub-threshold laser utilizing Pascal laser with endpoint-management software
  • Sham Comparator: Sham Laser Arm
    • Sham laser treatment

Clinical Trial Outcome Measures

Primary Measures

  • Change in macular drusen volume
    • Time Frame: 12 and 24 months
    • Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)

Secondary Measures

  • Change in visual acuity
    • Time Frame: 12 and 24 months
    • Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart
  • Development of geographic atrophy (GA) or choroidal neovascularization (CNV)
    • Time Frame: 2 years
    • Percentage of subjects who develop geographic atrophy or choroidal neovascularization by 24 months.

Participating in This Clinical Trial

Inclusion Criteria

1. Older than 60 years of age.

2. Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle

3. Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.

4. Able to give an informed consent.

Exclusion Criteria

1. Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).

2. Previous macular laser treatment.

3. Any previous ocular condition that may be associated with a risk of developing macular oedema.

4. Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).

5. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.

6. Important known allergies to sodium fluorescein dye used in angiography.

7. Ocular or periocular infections.

8. Planned intra-ocular surgery within one year.

9. Patient is unavailable for follow-up visits.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Collaborator
    • Bascom Palmer Eye Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steven R. Sanislo, Professor – Stanford University
  • Overall Official(s)
    • Steven Sanislo, MD, Principal Investigator, Stanford University

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