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

Sponsor:

Information provided by (Responsible Party):

University Hospital Inselspital, Berne

Study Description

Brief Summary:

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

Detailed Description:

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 Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Age-related macular degeneration

Genetic and Rare Diseases Information Center resources: Central Serous Chorioretinopathy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Patients receive selective retinal pigment epithelium laser treatment	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.

Outcome Measures

Primary Outcome Measures :

Visual Acuity according to ETDRS protocol [ Time Frame: 6 months ]

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Switzerland
Department of Ophthalmology, Bern University Hospital
Bern, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

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Study Chair:	Sebastian Wolf	Department of Ophthalmology, Bern University Hospital
Principal Investigator:	Andreas Ebneter	Department of Ophthalmology, Bern University Hospital

More Information

Publications:

Roider J, Michaud NA, Flotte TJ, Birngruber R. Response of the retinal pigment epithelium to selective photocoagulation. Arch Ophthalmol. 1992 Dec;110(12):1786-92.

Roider J, Hillenkamp F, Flotte T, Birngruber R. Microphotocoagulation: selective effects of repetitive short laser pulses. Proc Natl Acad Sci U S A. 1993 Sep 15;90(18):8643-7.

Roider J, Lindemann C, el-Hifnawi el-S, Laqua H, Birngruber R. Therapeutic range of repetitive nanosecond laser exposures in selective RPE photocoagulation. Graefes Arch Clin Exp Ophthalmol. 1998 Mar;236(3):213-9.

Roider J, Brinkmann R, Wirbelauer C, Birngruber R, Laqua H. Variability of RPE reaction in two cases after selective RPE laser effects in prophylactic treatment of drusen. Graefes Arch Clin Exp Ophthalmol. 1999 Jan;237(1):45-50.

Roider J, Brinkmann R, Wirbelauer C, Laqua H, Birngruber R. Subthreshold (retinal pigment epithelium) photocoagulation in macular diseases: a pilot study. Br J Ophthalmol. 2000 Jan;84(1):40-7.

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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

Keywords provided by University Hospital Inselspital, Berne:


selective laser therapy retinal pigment epithelium macular edema diabetic retinopathy	central serous chorioretinopathy age-related macular degeneration retinal vein occlusion

Additional relevant MeSH terms:

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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

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