NCT01019668

Brief Summary

The purpose of this study is to evaluate the effectiveness as well as the detrimental influence of half-dose and half-fluence modification of verteporfin photodynamic therapy (PDT) for the treatment of prolonged unresolved central serous chorioretinopathy (CSCR).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

1.1 years

First QC Date

November 19, 2009

Last Update Submit

July 22, 2011

Conditions

Central Serous Chorioretinopathy

Keywords

chorioretinopathyphotodynamic therapyreduced fluencereduced dose

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of both modification for the treatment of chronic CSCR Fluorescent leakage as regards to BCVA OCT changes

    within 6 months

Secondary Outcomes (1)

  • Detrimental influence on choroidal perfusion Represented by the decrease of fluorescent intensity In ICGA

    within 6 months

Study Arms (2)

verteporfin PDT, half-dose

ACTIVE COMPARATOR

use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy

Drug: Verteporfin PDT, half-doseDrug: verteporfin PDT, half-fluence

verteporfin PDT, half-fluence

ACTIVE COMPARATOR

use different modification of verteporfin PDT to treat prolonged unresolved central serous chorioretinopathy

Drug: Verteporfin PDT, half-doseDrug: verteporfin PDT, half-fluence

Interventions

Verteporfin PDT, half-doseDRUG

half the regular dose or half the regular laser fluence to treat prolonged unresolved CSCR

Also known as: visudyne
verteporfin PDT, half-doseverteporfin PDT, half-fluence
verteporfin PDT, half-fluenceDRUG

half the regular dose or half the regular laser fluence to treat prolonged unresolved CSCR

Also known as: visudyne
verteporfin PDT, half-doseverteporfin PDT, half-fluence

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with best-corrected visual acuity (BCVA) of 20/200 or better
  • Presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment (PED) involving the fovea on optical coherence tomography (OCT)
  • Presence of active angiographic leakage in fluorescein angiography (FA) caused by CSC but not CNV or other diseases
  • Abnormal dilated choroidal vasculature and other features in ICGA consistent with the diagnosis of CSC.

You may not qualify if:

  • Patients who received previous PDT or focal thermal laser photocoagulation for the treatment of CSC.
  • Patients had evidence of CNV, polypoidal choroidal vasculopathy, or other maculopathy on clinical examination, FA, or ICGA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

Location

Related Publications (1)

  • 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: 40522203DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Verteporfin

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Cheng-Kuo Cheng, MD

    Shin-Kong Wu Ho-Su Memorial Hospital, School of Medicine, Fu-Jen Catholic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 25, 2009

Study Start

November 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2011

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations

TW(1)