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

Not Applicable

Completed

• Conditions: Macular Degeneration; Retinal Drusen
• Interventions: Device: Pascal Retinal Laser Photocoagulator

• Registration Number: NCT02569892
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Study Start: 2016-09-01
• Primary Completion: 2020-02-01
• Study Completion: 2021-01-25
• Results First Submitted: 2021-03-09
• Results First Submitted QC: 2021-04-27
• Results First Posted: 2021-05-19
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser Arm	Pascal Retinal Laser Photocoagulator	Participants receive treatment with sub-threshold macular laser photocoagulation
Sham Laser Arm	Pascal Retinal Laser Photocoagulator	Participants receive sham treatment with sub-threshold macular laser photocoagulation (with power setting at zero)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States