Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Visual Acuity according to ETDRS protocol [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Retinal thickness measured by optical coherence tomography [ Time Frame: 6 months ]
  2. Leakage of fluorescein in fluorescein angiography [ Time Frame: 6 months ]
  3. Area of absent fundus autofluorescence [ Time Frame: 6 months ]
    Measured via fundus autofluorescence imaging


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Switzerland
Department of Ophthalmology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Layout table for investigator information
Study Chair: Sebastian Wolf Department of Ophthalmology, Bern University Hospital
Principal Investigator: Andreas Ebneter Department of Ophthalmology, Bern University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
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:
Layout table for MeSH terms
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