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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

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 14, 2014
Last Update Posted Date October 10, 2019
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
Visual Acuity according to ETDRS protocol [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina
Official Title  ICMJE Selective Retinal Pigment Epithelium Laser Therapy (SRT) for Macular Disease of the Retina
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Edema
  • Central Serous Chorioretinopathy
  • Retinal Vein Occlusion
  • Age-related Macular Degeneration
  • Retinal Neovascularization
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Treatment
Patients receive selective retinal pigment epithelium laser treatment
Intervention: Device: Selective retinal pigment epithelium laser therapy using the R:GEN Laser System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 12, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088151
Other Study ID Numbers  ICMJE 003/10
2011-MD-0006 ( Other Identifier: Swissmedic )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sebastian Wolf Department of Ophthalmology, Bern University Hospital
Principal Investigator: Andreas Ebneter Department of Ophthalmology, Bern University Hospital
PRS Account University Hospital Inselspital, Berne
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP