Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC)

NCT01574430 | Completed Phase 4

• 1 other identifier: PDTCSC-CHINA
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in BCVA

  1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

Secondary Outcomes (3)

• Leakage at RPE level in FA

  1 week

• Change from baseline in central retinal thickness

  1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

• The incidence rate of adverse event

  1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year

Study Arms (2)

50% dose PDT

ACTIVE COMPARATOR

patients in this group was given 50% verteporfin dose PDT

Procedure: PDT

30% dose PDT

EXPERIMENTAL

patients in this group was given 30% verteporfin dose PDT

Procedure: PDT

Interventions

PDT PROCEDURE

30% or 50% verteporfin dose PDT was given to patients with CSC

Also known as: photodynamic therapy

30% dose PDT; 50% dose PDT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with CSC
• patients signed the ICF
• patients with course of CSC less than 6 months
• patients did not undertake any treatment for CSC

You may not qualify if:

• patients with porphyria
• patients allergic to verteporfin
• pregnant or nursing women
• poor patients compliance
• sever liver dysfunction
• dioptric media opacities which make it difficult to exam fundus

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

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

• Zhao M, Zhang F, Chen Y, Dai H, Qu J, Dong C, Kang X, Liu Y, Yang L, Li Y, Zhou P, Pan CT, Zhang L, Liu P, Zhou H, Jiao X, Xiong Y, Tian R, Lu Y, Yu X, Li X. A 50% vs 30% dose of verteporfin (photodynamic therapy) for acute central serous chorioretinopathy: one-year results of a randomized clinical trial. JAMA Ophthalmol. 2015 Mar;133(3):333-40. doi: 10.1001/jamaophthalmol.2014.5312.

  PMID: 25555191 DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

1-phenyl-3,3-dimethyltriazene; Photochemotherapy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Mingwei Zhao, M.D

  Peking University People's Hospital

  STUDY DIRECTOR

• Youxin Chen, M.D

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

• Feng Zhang, M.D

  Beijing Tongren Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

• Hong Dai, M.D

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoxin Li, M.D

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 8, 2012
• First Posted: April 10, 2012
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

CN (1)