Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

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Brief Title

Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Official Title

Prospective Study on the Efficacy and Safety of Intravitreal Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Brief Summary

      The purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab
      injection versus low-fluence PDT in the treatment of chronic CSC.
    

Detailed Description

      Central serous chorioretinopathy (CSC) is characterized by serous detachment of the
      neurosensory retina. The pathophysiology of CSC is not certain and various theories are
      proposed including impaired function of retinal pigment epithelium (RPE), choroidal ischemia
      and choroidal hyperpermeability leading to RPE damage. Acute CSC with monofocal or paucifocal
      changes of RPE usually shows spontaneous resolution and has a favorable visual outcome.
      Chronic CSC is characterized by multifocal or diffuse decompensation of RPE associated with
      persistent detachment of neurosensory retina. This might lead to cystoid macular
      degeneration, foveal atrophy and damage to the foveal photoreceptor layer, consequently
      resulting in irreversible significant visual loss. Photodynamic therapy (PDT) was proposed
      for the treatment of chronic CSC. Modified parameters of PDT such as shortening of the time
      of laser emission and reduction of a total light energy have been suggested to reduce the
      irreversible damages induced by conventional PDT. Recently, intravitreal injection of
      antibody to vascular endothelial growth factor(VEGF) was proposed as a new treatment option
      based on the effect of anti-permeability. Several reports demonstrated acceptable outcomes
      after intravitreal bevacizumab injection, one of anti-VEGF agent. But the clinical results
      with ranibizumab are not reported yet. The purpose of this study is to compare the efficacy
      and safety of intravitreal ranibizumab injection versus low-fluence PDT in the treatment of
      chronic CSC.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment

Secondary Outcome

 Change From Baseline in logMAR BCVA

Condition

Chronic Central Serous Chorioretinopathy

Intervention

Verteporfin

Study Arms / Comparison Groups

 Low-fluence PDT with Verteporfin
Description:  Half the regular laser fluence PDT(Visudyne®; Novartis); a total light energy of 25J/cm2, a light dose rate of 300mW/cm2. If subretinal fluid was sustained after primary treatment, rescue treatment(ranibizumab injection) was considered

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

34

Start Date

July 2009

Completion Date

September 2012

Primary Completion Date

September 2012

Eligibility Criteria

        Inclusion Criteria:

          1. best-corrected visual acuity (BCVA) between 0.0 and 1.0 logarithm of the minimal angle
             of resolution (logMAR)

          2. presence of subfoveal fluid persisting for 3 months or more on optical coherence
             tomography (OCT)

          3. presence of leakage and multifocal/diffuse RPE decompensation on fluorescein
             angiography (FA)

          4. choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on
             indocyanine angiography (ICGA)

        Exclusion Criteria:

          1. previous treatment, such as laser photocoagulation, PDT, intravitreal injection of
             steroid or anti-VEGF agent

          2. evidence of choroidal neovascularization

          3. any other ocular diseases that could affect visual acuity

          4. systemic steroid treatment in the previous 12 months

          5. media opacity such as cataract that could interfere with adequate acquisition of OCT,
             FA and ICGA images
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jang Won Heo, Professor, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01325181

Organization ID

NOV001


Responsible Party

Sponsor-Investigator

Study Sponsor

Jang Won Heo

Collaborators

 Novartis Korea Ltd.

Study Sponsor

Jang Won Heo, Professor, Principal Investigator, Seoul National University Hospital


Verification Date

April 2013