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Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

NCT ID: NCT00802906

Last Updated: 2012-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Central Serous Chorioretinopathy

Keywords

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micropulselaserphotocoagulation bevacizumab CSC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

1.5 mg bevacizumab single injection and on demand if leakage is persistent or recurs

Group Type ACTIVE_COMPARATOR

subthreshold micropulselaser

Intervention Type DEVICE

on demand if leakage is persistent or recurs after initial treatment

bevacizumab

Intervention Type DRUG

1.5 mg initial intravitreal injection

2

initial selective subthreshold micropulselasercoagulation and on demand if leakage is persistent or recurs

Group Type ACTIVE_COMPARATOR

subthreshold micropulselaser

Intervention Type DEVICE

on demand if leakage is persistent or recurs after initial treatment

3

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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subthreshold micropulselaser

on demand if leakage is persistent or recurs after initial treatment

Intervention Type DEVICE

bevacizumab

1.5 mg initial intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CSC of \>4 months duration

Exclusion Criteria

* History of macular or chorioretinal inflammation
* Lens / corneal opacities
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Koss

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Koss, MD

Role: PRINCIPAL_INVESTIGATOR

ZAU Department of Vitreoretinal surgery

Locations

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ZAU Department of VR surgery

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 22079961 (View on PubMed)

Other Identifiers

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MK-RCS-2008

Identifier Type: -

Identifier Source: org_study_id