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

Phase 1

Completed

• Conditions: Chronic Central Serous Chorioretinopathy
• Interventions: Drug: Verteporfin; Drug: ranibizumab

• Registration Number: NCT01325181
• Lead Sponsor: Jang Won Heo

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-03-25
• Study First Submitted QC: 2011-03-27
• Study First Posted: 2011-03-29
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-04
• Results First Submitted: 2013-04-02
• Results First Submitted QC: 2013-04-05
• Last Update Submitted: 2013-04-05
• Results First Posted: 2013-05-27
• Last Update Posted: 2013-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-fluence PDT with Verteporfin	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
Ranibizumab	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

Primary Outcome Measures

Name	Time	Method
Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment	12 months	number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Leakage on Fluorescein Angiography	12 months	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	12 months	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	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
Number of Participants With Adverse Event	12 months	number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events
Change From Baseline in logMAR BCVA	12 months	the changes from baseline in logMAR BCVA throughout the follow-up period
Change From Baseline in Central Foveal Thickness on OCT	12 months	the change from baseline in central foveal thickness measured by OCT throughout the follow-up period

Trial Locations

Locations (1)

• Department of Ophthalmology, Seoul National University College of Medicine; 🇰🇷 Seoul, Gyeonggi-do, Korea, Republic of