Selective RPE Laser Treatment (SRT) for Various Macular Diseases

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2006 by University of Regensburg. Recruitment status was Active, not recruiting

First Received on November 24, 2006. Last Updated on January 11, 2010 History of Changes

Sponsor:	University of Regensburg
Collaborator:	Dr. Werner Jackstaedt Foundation
Information provided by:	University of Regensburg
ClinicalTrials.gov Identifier:	NCT00403884

Purpose

In this prospective clinical study SRT is performed with various pulse durations at 1.7µs and additionally 200ns to evaluate the different clinical effects of both laser regimens. The macular diseases to be treated are drusen maculopathy and geographic atrophy due to age-related macular degeneration as well as diabetic macular edema and central serous chorioretinopathy.

The beneficial effect in laser treatment is thought to be associated with the restoration of a new barrier of retinal pigment epithelium cells. If this theory is true, the destruction of the photoreceptors causing visual field defects would be only an unwanted and unnecessary side effect. Thus, SRT is able to avoid these unintentional side effects and to achieve the benefit by just treating the RPE.

In this study the clinical effect of SRT for these diseases is evaluated on a long-term basis.

Condition	Intervention
Age-Related Macular Degeneration Diabetic Maculopathy Central Serous Chorioretinopathy	Procedure: Selective RPE laser treatment

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Selective RPE Laser Treatment (SRT) for Various Macular Diseases

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema Macular Degeneration

U.S. FDA Resources

Further study details as provided by University of Regensburg:

Primary Outcome Measures:

Visual acuity [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

drusen reduction [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
area of geographic atrophy [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
reduction of retinal edema [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2004
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

interventional SRT laser treatment

Other Name: SRT vario, Medical Laser Center, Luebeck, Germany

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

symmetric drusen maculopathy with soft drusen both eyes
symmetric geographic atrophy both eyes
diabetic macular edema single eye
acute or chronic central serous chorioretinopathy

Exclusion Criteria:

previous laser treatment
previous intravitreal injections
choroidal neovascularization
visual acuity > 0.1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403884

Locations

Germany
University Eye Hospital Regensburg
Regensburg, Germany, 93042

Sponsors and Collaborators

University of Regensburg

Dr. Werner Jackstaedt Foundation

Investigators

Principal Investigator:

Carsten Framme, MD

University Eye Hospital Regensburg

More Information

No publications provided

Responsible Party:	PD Dr. med. Carsten Framme, FEBO, MHM, University Eye Hospital Regensburg
ClinicalTrials.gov Identifier:	NCT00403884 History of Changes
Other Study ID Numbers:	University Eye Hospital SRT
Study First Received:	November 24, 2006
Last Updated:	January 11, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Regensburg:

Drusen
Geographic atrophy
diabetes

macular edema
laser
retinal pigment epithelium

Additional relevant MeSH terms:

Macular Degeneration
Central Serous Chorioretinopathy
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012