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

NCT01325181 | Completed Phase 1 Results DMC

• 1 other identifier: NOV001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Central Serous Chorioretinopathy

Keywords

Chronic central serous chorioretinopathy; Ranibizumab; Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change From Baseline in logMAR BCVA

  12 months

• Change From Baseline in Central Foveal Thickness on OCT

  12 months

• Number of Participants With Leakage on Fluorescein Angiography

  12 months

• Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography

  12 months

• Number of Participants Who Underwent Rescue Treatment

  12 months

Study Arms (2)

Low-fluence PDT with Verteporfin

ACTIVE COMPARATOR

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

Ranibizumab

ACTIVE COMPARATOR

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

Interventions

Verteporfin DRUG

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

Also known as: Visudyne

Low-fluence PDT with Verteporfin

ranibizumab DRUG

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

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jang Won Heo: lead
• Novartis Korea Ltd.: collaborator

Study Sites (1)

• Department of Ophthalmology, Seoul National University College of Medicine

Seoul, Gyeonggi-do, South Korea

Location

Related Publications (2)

• Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.

  PMID: 40522203 DERIVED

• 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.

  PMID: 21742303 DERIVED

MeSH Terms

Interventions

Verteporfin; Ranibizumab

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jang Won Heo
• Organization: Seoul National University Hospital

hjw68@snu.ac.kr

82220720836

Study Officials

• Jang Won Heo, Professor

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: March 29, 2011
• Study Start: July 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 27, 2013
• Results First Posted: May 27, 2013

Record last verified: 2013-04

Locations

KR (1)