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

NCT02088151 | Terminated

• 2 other identifiers: 003/102011-MD-0006
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Edema; Central Serous Chorioretinopathy; Retinal Vein Occlusion; Age-related Macular Degeneration; Retinal Neovascularization

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual Acuity according to ETDRS protocol

  6 months

Secondary Outcomes (3)

• Retinal thickness measured by optical coherence tomography

  6 months

• Leakage of fluorescein in fluorescein angiography

  6 months

• Area of absent fundus autofluorescence

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive selective retinal pigment epithelium laser treatment

Device: Selective retinal pigment epithelium laser therapy using the R:GEN Laser System

Interventions

Selective retinal pigment epithelium laser therapy using the R:GEN Laser System DEVICE

Patients receive selective retinal pigment epithelium laser treatment using the R:GEN Laser System by Lutronic Corporation, Korea.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Macular ischemia
• Retinal hemorrhage impeding retinal laser treatment
• Subretinal neovascular membrane
• Vitreous hemorrhage
• Allergy to fluorescein
• Participation in other clinical trials

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Ophthalmology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (5)

• 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. doi: 10.1001/archopht.1992.01080240126045.

  PMID: 1463423 BACKGROUND

• 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. doi: 10.1073/pnas.90.18.8643.

  PMID: 8378341 BACKGROUND

• 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. doi: 10.1007/s004170050067.

  PMID: 9541826 BACKGROUND

• 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. doi: 10.1007/s004170050193.

  PMID: 9951641 BACKGROUND

• 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. doi: 10.1136/bjo.84.1.40.

  PMID: 10611098 BACKGROUND

MeSH Terms

Conditions

Macular Edema; Central Serous Chorioretinopathy; Retinal Vein Occlusion; Macular Degeneration; Retinal Neovascularization; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Sebastian Wolf

  Department of Ophthalmology, Bern University Hospital

  STUDY CHAIR

• Andreas Ebneter

  Department of Ophthalmology, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 14, 2014
• Study Start: June 1, 2010
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

CH (1)