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

Study Overview
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Brief Summary
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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.

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

Conditions
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Macular Degeneration, Retinal Drusen

Intervention / Treatment
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* Device: Pascal Retinal Laser Photocoagulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Older than 60 years of age. Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT. Able to give an informed consent. Exclusion Criteria: Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF). Previous macular laser treatment. Any previous ocular condition that may be associated with a risk of developing macular oedema. 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). Presence of other macular disease such as epiretinal membrane, macular telangiectasia. Important known allergies to sodium fluorescein dye used in angiography. Ocular or periocular infections. Planned intra-ocular surgery within one year. Patient is unavailable for follow-up visits.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Arm<br>Participants receive treatment with sub-threshold macular laser photocoagulation | Device: Pascal Retinal Laser Photocoagulator<br>* Sub-threshold macular laser treatment with Pascal laser Endpoint Management System<br>|
| Sham Comparator: Sham Laser Arm<br>Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero) | Device: Pascal Retinal Laser Photocoagulator<br>* Sub-threshold macular laser treatment with Pascal laser Endpoint Management System<br>|

What is the study measuring?
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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 |