Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

Central Serous Chorioretinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802906
• Other study ID #: MK-RCS-2008
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: September 26, 2012
• Start date: May 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2012
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion criteria:

• CSC of >4 months duration

Exclusion Criteria:

• History of macular or chorioretinal inflammation

• Lens / corneal opacities

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Device:
• subthreshold micropulselaser
on demand if leakage is persistent or recurs after initial treatment

Drug:
• bevacizumab
1.5 mg initial intravitreal injection

Locations

Country	Name	City	State
Germany	ZAU Department of VR surgery	Frankfurt / Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA in EDTRS values		24 months	No
Secondary	OCT, leakage in FA, defects in satic perimetry		24 months	No