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Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00802906
First Posted: December 5, 2008
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospitals
  Purpose
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.

Condition Intervention
Central Serous Chorioretinopathy Device: subthreshold micropulselaser Drug: bevacizumab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by Michael Koss, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • BCVA in EDTRS values [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • OCT, leakage in FA, defects in satic perimetry [ Time Frame: 24 months ]

Enrollment: 12
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
1.5 mg bevacizumab single injection and on demand if leakage is persistent or recurs
Device: subthreshold micropulselaser
on demand if leakage is persistent or recurs after initial treatment
Drug: bevacizumab
1.5 mg initial intravitreal injection
Active Comparator: 2
initial selective subthreshold micropulselasercoagulation and on demand if leakage is persistent or recurs
Device: subthreshold micropulselaser
on demand if leakage is persistent or recurs after initial treatment
No Intervention: 3
control

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • CSC of >4 months duration

Exclusion Criteria:

  • History of macular or chorioretinal inflammation
  • Lens / corneal opacities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802906


Locations
Germany
ZAU Department of VR surgery
Frankfurt / Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Michael Koss, MD ZAU Department of Vitreoretinal surgery
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Koss, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00802906     History of Changes
Other Study ID Numbers: MK-RCS-2008
First Submitted: December 4, 2008
First Posted: December 5, 2008
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Michael Koss, Johann Wolfgang Goethe University Hospitals:
micropulselaserphotocoagulation
bevacizumab
CSC

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents