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

NCT ID: NCT01574430

Last Updated: 2016-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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Conditions

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Central Serous Chorioretinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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50% dose PDT

patients in this group was given 50% verteporfin dose PDT

Group Type ACTIVE_COMPARATOR

PDT

Intervention Type PROCEDURE

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

30% dose PDT

patients in this group was given 30% verteporfin dose PDT

Group Type EXPERIMENTAL

PDT

Intervention Type PROCEDURE

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

Interventions

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PDT

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

Intervention Type PROCEDURE

Other Intervention Names

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photodynamic therapy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mingwei Zhao

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingwei Zhao, M.D

Role: STUDY_DIRECTOR

Peking University People's Hospital

Youxin Chen, M.D

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College

Feng Zhang, M.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital of Capital Medical University

Hong Dai, M.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital

Xiaoxin Li, M.D

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

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People's Hospital of Peking University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40522203 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25555191 (View on PubMed)

Other Identifiers

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PDTCSC-CHINA

Identifier Type: -

Identifier Source: org_study_id

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