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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedSeptember 27, 2012
September 1, 2012
3.5 years
December 4, 2008
September 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BCVA in EDTRS values
24 months
Secondary Outcomes (1)
OCT, leakage in FA, defects in satic perimetry
24 months
Study Arms (3)
1
ACTIVE COMPARATOR1.5 mg bevacizumab single injection and on demand if leakage is persistent or recurs
2
ACTIVE COMPARATORinitial selective subthreshold micropulselasercoagulation and on demand if leakage is persistent or recurs
3
NO INTERVENTIONcontrol
Interventions
on demand if leakage is persistent or recurs after initial treatment
Eligibility Criteria
You may qualify if:
- CSC of \>4 months duration
You may not qualify if:
- History of macular or chorioretinal inflammation
- Lens / corneal opacities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ZAU Department of VR surgery
Frankfurt am Main, Hesse, 60590, Germany
Related Publications (1)
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.
PMID: 22079961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Koss, MD
ZAU Department of Vitreoretinal surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
May 1, 2007
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
September 27, 2012
Record last verified: 2012-09