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

This study has been completed.
Sponsor:
Collaborator:
Novartis Korea Ltd.
Information provided by (Responsible Party):
Jang Won Heo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01325181
First received: March 25, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Chronic Central Serous Chorioretinopathy
Drug: Verteporfin
Drug: ranibizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study


Secondary Outcome Measures:
  • Change From Baseline in logMAR BCVA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    the changes from baseline in logMAR BCVA throughout the follow-up period

  • Change From Baseline in Central Foveal Thickness on OCT [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    the change from baseline in central foveal thickness measured by OCT throughout the follow-up period

  • Number of Participants With Leakage on Fluorescein Angiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period

  • Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period

  • Number of Participants Who Underwent Rescue Treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group

  • Number of Participants With Adverse Event [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events


Enrollment: 34
Study Start Date: July 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-fluence PDT with Verteporfin
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
Drug: Verteporfin
a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
Other Name: Visudyne
Active Comparator: Ranibizumab
Consecutive Intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months. If subretinal fluid was sustained after primary treatment, rescue treatment(low-fluence photodynamic therapy) was considered
Drug: ranibizumab
Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months
Other Name: Lucentis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325181

Locations
Korea, Republic of
• Department of Ophthalmology, Seoul National University College of Medicine
Seoul, Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
Jang Won Heo
Novartis Korea Ltd.
Investigators
Principal Investigator: Jang Won Heo, Professor Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jang Won Heo, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01325181     History of Changes
Other Study ID Numbers: NOV001
Study First Received: March 25, 2011
Results First Received: April 2, 2013
Last Updated: April 5, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Chronic central serous chorioretinopathy
Ranibizumab
Photodynamic therapy

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014