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

Stanford University

Status: Completed

Conditions: Macular Degeneration; Retinal Drusen

Treatments: Device: Pascal Retinal Laser Photocoagulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02569892

IRB-33991

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups

Laser Arm

Experimental group

Description:

Participants receive treatment with sub-threshold macular laser photocoagulation

Treatment:

Device: Pascal Retinal Laser Photocoagulator

Sham Laser Arm

Sham Comparator group

Description:

Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)

Treatment:

Device: Pascal Retinal Laser Photocoagulator