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| Sponsored by: |
Johann Wolfgang Goethe University Hospitals |
|---|---|
| Information provided by: | Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT00802906 |
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: | Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment |
| Official Title: | Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy |
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
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
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2: Active Comparator
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
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3: No Intervention
control
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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| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michael Koss, MD | 069630156 ext 49 | michael.koss@kgu.de |
| Germany, Hessen | |
| ZAU Department of VR surgery | Recruiting |
| Frankfurt / Main, Hessen, Germany, 60590 | |
| Contact: Michael Koss, MD 069630156 ext 49 michael.koss@kgu.de | |
| Principal Investigator: | Michael Koss, MD | ZAU Department of Vitreoretinal surgery |
More Information
| Responsible Party: | ZAU - department of VitreoRetinal surgery ( Michael Koss ) |
| Study ID Numbers: | MK-RCS-2008 |
| Study First Received: | December 4, 2008 |
| Last Updated: | December 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00802906 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
micropulselaserphotocoagulation bevacizumab CSC |
|
Bevacizumab Central serous chorioretinopathy |
|
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |
