Skip to main content
OpenTrials
Completed

NCT Number: NCT01325181

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Central Serous Chorioretinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

• Department of Ophthalmology, Seoul National University College of Medicine

Seoul, Gyeonggi-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verteporfin

Drug

a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery

Other names: Visudyne

ranibizumab

Drug

Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months

Other names: Lucentis

Primary outcomes

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

    Time frame: 12 months

    number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study

Secondary outcomes

  1. Change From Baseline in logMAR BCVA

    Time frame: 12 months

    the changes from baseline in logMAR BCVA throughout the follow-up period

  2. Change From Baseline in Central Foveal Thickness on OCT

    Time frame: 12 months

    the change from baseline in central foveal thickness measured by OCT throughout the follow-up period

  3. Number of Participants With Leakage on Fluorescein Angiography

    Time frame: 12 months

    number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period

  4. Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography

    Time frame: 12 months

    change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period

  5. Number of Participants Who Underwent Rescue Treatment

    Time frame: 12 months

    number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group

  6. Number of Participants With Adverse Event

    Time frame: 12 months

    number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events

Sponsors and collaborators

Lead sponsor

Jang Won Heo

Other

Collaborators

  • Novartis Korea Ltd.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2011
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.