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

Primary Purpose

Chronic Central Serous Chorioretinopathy

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Verteporfin
ranibizumab
Sponsored by
Jang Won Heo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Central Serous Chorioretinopathy focused on measuring Chronic central serous chorioretinopathy, Ranibizumab, Photodynamic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • • Department of Ophthalmology, Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low-fluence PDT with Verteporfin

Ranibizumab

Arm 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

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

Outcomes

Primary Outcome Measures

Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment
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
the changes from baseline in logMAR BCVA throughout the follow-up period
Change From Baseline in Central Foveal Thickness on OCT
the change from baseline in central foveal thickness measured by OCT throughout the follow-up period
Number of Participants With Leakage on Fluorescein Angiography
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
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
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
number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events

Full Information

First Posted
March 25, 2011
Last Updated
April 5, 2013
Sponsor
Jang Won Heo
Collaborators
Novartis Korea Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01325181
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jang Won Heo
Collaborators
Novartis Korea Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Central Serous Chorioretinopathy
Keywords
Chronic central serous chorioretinopathy, Ranibizumab, Photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-fluence PDT with Verteporfin
Arm Type
Active Comparator
Arm 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
Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Verteporfin
Other Intervention Name(s)
Visudyne
Intervention Description
a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months
Primary Outcome Measure Information:
Title
Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment
Description
number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change From Baseline in logMAR BCVA
Description
the changes from baseline in logMAR BCVA throughout the follow-up period
Time Frame
12 months
Title
Change From Baseline in Central Foveal Thickness on OCT
Description
the change from baseline in central foveal thickness measured by OCT throughout the follow-up period
Time Frame
12 months
Title
Number of Participants With Leakage on Fluorescein Angiography
Description
number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period
Time Frame
12 months
Title
Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography
Description
change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period
Time Frame
12 months
Title
Number of Participants Who Underwent Rescue Treatment
Description
number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group
Time Frame
12 months
Title
Number of Participants With Adverse Event
Description
number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: best-corrected visual acuity (BCVA) between 0.0 and 1.0 logarithm of the minimal angle of resolution (logMAR) presence of subfoveal fluid persisting for 3 months or more on optical coherence tomography (OCT) presence of leakage and multifocal/diffuse RPE decompensation on fluorescein angiography (FA) choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on indocyanine angiography (ICGA) Exclusion Criteria: previous treatment, such as laser photocoagulation, PDT, intravitreal injection of steroid or anti-VEGF agent evidence of choroidal neovascularization any other ocular diseases that could affect visual acuity systemic steroid treatment in the previous 12 months media opacity such as cataract that could interfere with adequate acquisition of OCT, FA and ICGA images
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jang Won Heo, Professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
• Department of Ophthalmology, Seoul National University College of Medicine
City
Seoul
State/Province
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21742303
Citation
Bae SH, Heo JW, Kim C, Kim TW, Lee JY, Song SJ, Park TK, Moon SW, Chung H. A randomized pilot study of low-fluence photodynamic therapy versus intravitreal ranibizumab for chronic central serous chorioretinopathy. Am J Ophthalmol. 2011 Nov;152(5):784-92.e2. doi: 10.1016/j.ajo.2011.04.008. Epub 2011 Jul 13.
Results Reference
derived

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

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