Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00802906
First received: December 4, 2008
Last updated: September 26, 2012
Last verified: September 2012
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • BCVA in EDTRS values [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OCT, leakage in FA, defects in satic perimetry [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Active Comparator: 2
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
No Intervention: 3
control

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • CSC of >4 months duration

Exclusion Criteria:

  • History of macular or chorioretinal inflammation
  • Lens / corneal opacities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802906

Locations
Germany
ZAU Department of VR surgery
Frankfurt / Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Michael Koss, MD ZAU Department of Vitreoretinal surgery
  More Information

No publications provided by Johann Wolfgang Goethe University Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Koss, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00802906     History of Changes
Other Study ID Numbers: MK-RCS-2008
Study First Received: December 4, 2008
Last Updated: September 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
micropulselaserphotocoagulation
bevacizumab
CSC

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014