Back to results

Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

Primary Purpose

Central Serous Chorioretinopathy

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

subthreshold micropulselaser

bevacizumab

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring micropulselaserphotocoagulation, bevacizumab, CSC

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

CSC of >4 months duration

Exclusion Criteria:

History of macular or chorioretinal inflammation
Lens / corneal opacities

Sites / Locations

ZAU Department of VR surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

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

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

control

Outcomes

Primary Outcome Measures

BCVA in EDTRS values

Secondary Outcome Measures

OCT, leakage in FA, defects in satic perimetry

Full Information

NCT ID

NCT00802906

First Posted

December 4, 2008

Last Updated

September 26, 2012

Sponsor

Johann Wolfgang Goethe University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00802906

Brief Title

Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

Official Title

Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Serous Chorioretinopathy

Keywords

micropulselaserphotocoagulation, bevacizumab, CSC

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

No Intervention

Arm Description

control

Intervention Type

Device

Intervention Name(s)

subthreshold micropulselaser

Intervention Description

on demand if leakage is persistent or recurs after initial treatment

Intervention Type

Drug

Intervention Name(s)

bevacizumab

Intervention Description

1.5 mg initial intravitreal injection

Primary Outcome Measure Information:

Title

BCVA in EDTRS values

Time Frame

24 months

Secondary Outcome Measure Information:

Title

OCT, leakage in FA, defects in satic perimetry

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: CSC of >4 months duration Exclusion Criteria: History of macular or chorioretinal inflammation Lens / corneal opacities

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Koss, MD

Organizational Affiliation

ZAU Department of Vitreoretinal surgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

ZAU Department of VR surgery

City

Frankfurt / Main

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22079961

Citation

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.

Results Reference

derived

Learn more about this trial

Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

We'll reach out to this number within 24 hrs