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

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 Overview

• Status: Completed
• Conditions: Macular Degeneration; Retinal Drusen
• Intervention / Treatment: Device: Pascal Retinal Laser Photocoagulator

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute at Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laser Arm; Participants receive treatment with sub-threshold macular laser photocoagulation	Device: Pascal Retinal Laser Photocoagulator; Sub-threshold macular laser treatment with Pascal laser Endpoint Management System
SHAM_COMPARATOR: Sham Laser Arm; Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)	Device: Pascal Retinal Laser Photocoagulator; Sub-threshold macular laser treatment with Pascal laser Endpoint Management System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Macular Drusen Volume	Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)	baseline, 6, 12, and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Acuity	Mean change in best-corrected visual acuity as measured using early treatment diabetic retinopathy study (ETDRS) chart - average number of letters seen on chart	baseline, 6, 12, and 24 months
Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)	Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.	2 years

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Bascom Palmer Eye Institute
• Investigators: Principal Investigator: Steven Sanislo, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): January 25, 2021

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (ESTIMATE): October 7, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Retinal Drusen
• Other Study ID Numbers: IRB-33991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO