NCT00864773

Brief Summary

The pathophysiology of central serous chorioretinopathy remains controversial. traditional treatment is laser photocoagulation or photodynamic therapy.Recently Bevacizumab (Avastin, Genetech),an antibody to vascular endothelial growth factor (VEGF),has known antipermeability properties and therefore may theoretically reverse the changes seen in central serous chorioretinopathy. The aim of this study is To investigate concentrations of growth factors and inflammatory cytokines and to report the effect of therapy with bevacizumab in eyes with central serous chorioretinopathy

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

March 18, 2009

Last Update Submit

March 18, 2009

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

  • Concentrations of growth factors and inflammatory cytokines in Aqueous humor

    at baseline

Secondary Outcomes (1)

  • Central macular thickness at optical coherence tomography

    baseline, 1 month, 3 months, 6 months

Interventions

intravitreal injection with anterior paracentesisPROCEDURE

0.1cc Aqueous humor samples were taken each time an intravitreal injection of bevacizumab (2.5 mg in 0.1 ml)

Also known as: Bevacizumab (Avastin, Genetech), an antibody to vascular endothelial growth factor (VEGF)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a diagnosis of central serous chorioretinopathy
  • Idiopathic neurosensory retinal elevation demonstrated by optical coherent tomography
  • Presence of focal leaks at the level of the RPE on fluorescein angiography

You may not qualify if:

  • Known side effects of systemic bevacizumab administration
  • Have a significant cardiovascular or thromboembolic history or were pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Intravitreal InjectionsBevacizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeuticsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 19, 2009

Record last verified: 2009-03