Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina
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ClinicalTrials.gov Identifier: NCT02088151 |
Recruitment Status :
Suspended
(Device currently not available)
First Posted : March 14, 2014
Last Update Posted : October 10, 2019
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Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects.
In this study, patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration will be treated with SRT. Patients will be assessed 1, 3 and 6 months after treatment.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Macular Edema Central Serous Chorioretinopathy Retinal Vein Occlusion Age-related Macular Degeneration Retinal Neovascularization | Device: Selective retinal pigment epithelium laser therapy using the R:GEN Laser System | Not Applicable |
Background
Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). In age-related macular degeneration, regression of drusen has been observed after laser treatment with convention laser or SRT. Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects.
Objective
To assess the efficacy of SRT in patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration. Up to five patients with proliferative diabetic retinopathy can optionally be treated with SRT too.
Methods
At baseline and during follow-up patients will receive a full ophthalmic examination including optical coherence tomography, fundus autofluorescence imaging, fluorescein angiography (FA), and visual acuity testing. SRT (R:GEN Laser System by Lutronic Corporation, Korea) will be delivered under topical anesthesia. For titration of energy spots will first be applied outside the major arcades. Immediately thereafter FA will be performed for extrapolation of the laser dose, since the treatment is sub-threshold and laser spots will not be visible biomicroscopically. The patient will then be treated at the discretion of the ophthalmologist with up to 500 laser burns. One hour after the laser treatment FA will be repeated to confirm the treatment effect. Patients will be assessed 1, 3 and 6 months after treatment. Pulse duration can be chosen between 200ns and 2μs. The maximum pulse energy will be 1mJ. 1-30 pulses will be applied for every laser burn at a frequency of 100Hz.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Selective Retinal Pigment Epithelium Laser Therapy (SRT) for Macular Disease of the Retina |
Study Start Date : | June 2010 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Patients receive selective retinal pigment epithelium laser treatment
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Device: Selective retinal pigment epithelium laser therapy using the R:GEN Laser System
Patients receive selective retinal pigment epithelium laser treatment using the R:GEN Laser System by Lutronic Corporation, Korea. |
- Visual Acuity according to ETDRS protocol [ Time Frame: 6 months ]
- Retinal thickness measured by optical coherence tomography [ Time Frame: 6 months ]
- Leakage of fluorescein in fluorescein angiography [ Time Frame: 6 months ]
- Area of absent fundus autofluorescence [ Time Frame: 6 months ]Measured via fundus autofluorescence imaging

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 or over
- Written informed consent
- Willingness to attend follow-up visits
- Central serous chorioretinopathy affecting visual acuity
- Macular edema from branch retinal vein occlusion
- Macular edema from diabetic microangiopathy
- Age-related macular degeneration with confluent soft drusen
- Age-related macular degeneration with geographic atrophy
Exclusion Criteria
- Macular ischemia
- Retinal hemorrhage impeding retinal laser treatment
- Subretinal neovascular membrane
- Vitreous hemorrhage
- Allergy to fluorescein
- Participation in other clinical trials

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088151
Switzerland | |
Department of Ophthalmology, Bern University Hospital | |
Bern, Switzerland, 3010 |
Study Chair: | Sebastian Wolf | Department of Ophthalmology, Bern University Hospital | |
Principal Investigator: | Andreas Ebneter | Department of Ophthalmology, Bern University Hospital |
Responsible Party: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT02088151 |
Other Study ID Numbers: |
003/10 2011-MD-0006 ( Other Identifier: Swissmedic ) |
First Posted: | March 14, 2014 Key Record Dates |
Last Update Posted: | October 10, 2019 |
Last Verified: | October 2019 |
selective laser therapy retinal pigment epithelium macular edema diabetic retinopathy |
central serous chorioretinopathy age-related macular degeneration retinal vein occlusion |
Macular Degeneration Macular Edema Retinal Vein Occlusion Central Serous Chorioretinopathy Retinal Neovascularization Neovascularization, Pathologic Retinal Degeneration Retinal Diseases |
Eye Diseases Metaplasia Pathologic Processes Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |