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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569892
• Other study ID #: IRB-33991
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: January 25, 2021

Study information

• Verified date: October 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 25, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Retinal Drusen

Intervention

Device:
• Pascal Retinal Laser Photocoagulator
Sub-threshold macular laser treatment with Pascal laser Endpoint Management System

Locations

Country	Name	City	State
United States	Byers Eye Institute at Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Bascom Palmer Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)	Count of eyes that develop geographic atrophy or choroidal neovascularization by 24 months.	2 years