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
Sponsor:
Collaborator:
Dr. Werner Jackstaedt Foundation
Information provided by:
University of Regensburg
ClinicalTrials.gov Identifier:
NCT00403884
First received: November 24, 2006
Last updated: January 11, 2010
Last verified: November 2006
  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:


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:
    Procedure: Selective RPE laser treatment
    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
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, see Learn About Clinical Studies.

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 July 24, 2014