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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

Brief Summary:
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 or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Device: subthreshold micropulselaser Drug: bevacizumab Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : May 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
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



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

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


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

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

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

Keywords provided by Michael Koss, Johann Wolfgang Goethe University Hospital:
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