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Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

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ClinicalTrials.gov Identifier: NCT00802906
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospital

December 4, 2008
December 5, 2008
September 27, 2012
May 2007
November 2010   (Final data collection date for primary outcome measure)
BCVA in EDTRS values [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT00802906 on ClinicalTrials.gov Archive Site
OCT, leakage in FA, defects in satic perimetry [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)
Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy
The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should non-selectively stop the RPE leakage.
To evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation in twelve eyey per group versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells. BCVA in EDTRS score, OCT, and leakage in FLA, static perimetry of both groups will be correlated to a control group without treatment over 10 months.
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Central Serous Chorioretinopathy
  • Device: subthreshold micropulselaser
    on demand if leakage is persistent or recurs after initial treatment
  • Drug: bevacizumab
    1.5 mg initial intravitreal injection
  • Active Comparator: 1
    1.5 mg bevacizumab single injection and on demand if leakage is persistent or recurs
    Interventions:
    • Device: subthreshold micropulselaser
    • Drug: bevacizumab
  • Active Comparator: 2
    initial selective subthreshold micropulselasercoagulation and on demand if leakage is persistent or recurs
    Intervention: Device: subthreshold micropulselaser
  • No Intervention: 3
    control
Koss MJ, Beger I, Koch FH. Subthreshold diode laser micropulse photocoagulation versus intravitreal injections of bevacizumab in the treatment of central serous chorioretinopathy. Eye (Lond). 2012 Feb;26(2):307-14. doi: 10.1038/eye.2011.282. Epub 2011 Nov 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Same as current
December 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • CSC of >4 months duration

Exclusion Criteria:

  • History of macular or chorioretinal inflammation
  • Lens / corneal opacities
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00802906
MK-RCS-2008
No
Not Provided
Not Provided
Michael Koss, Johann Wolfgang Goethe University Hospital
Johann Wolfgang Goethe University Hospital
Not Provided
Principal Investigator: Michael Koss, MD ZAU Department of Vitreoretinal surgery
Johann Wolfgang Goethe University Hospital
September 2012

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