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

Chronic Central Serous Chorioretinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325181
• Other study ID #: NOV001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 25, 2011
• Last updated: April 5, 2013
• Start date: July 2009
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Chronic Central Serous Chorioretinopathy

Intervention

Drug:
• Verteporfin
a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
• ranibizumab
Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months

Locations

Country	Name	City	State
Korea, Republic of	• Department of Ophthalmology, Seoul National University College of Medicine	Seoul	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Jang Won Heo	Novartis Korea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	No
Secondary	Change From Baseline in logMAR BCVA	the changes from baseline in logMAR BCVA throughout the follow-up period	12 months	No
Secondary	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	12 months	No
Secondary	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	12 months	No
Secondary	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	12 months	No
Secondary	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	12 months	No
Secondary	Number of Participants With Adverse Event	number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events	12 months	Yes