NCT03497000

Brief Summary

OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 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

September 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 28, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

March 28, 2018

Last Update Submit

April 14, 2018

Conditions

Central Serous ChorioretinopathyTomography, Optical Coherence

Keywords

optical coherence tomography angiographycentral serous chorioretinopathyphotodynamic therapy

Outcome Measures

Primary Outcomes (1)

  • Number of patients with subretinal fluid resolution on OCT after PDT of two groups

    3 months

Secondary Outcomes (3)

  • Number of patients with leakage point resolution on FFA after PDT of two groups

    3 months

  • Number of recurrent CSC after PDT of two groups

    3 months

  • BCVA (best corrected visual acuity) at every follow-up of two groups

    1 month, 3 months

Study Arms (2)

OCTA group

EXPERIMENTAL

Patients in this group underwent OCTA-guided half-dose photodynamic therapy.

Procedure: OCTA-guided Photodynamic therapy

ICGA group

ACTIVE COMPARATOR

Patients in this group underwent normal ICGA-guided half dose photodynamic therapy.

Procedure: ICGA-guided Photodynamic therapy

Interventions

OCTA-guided Photodynamic therapyPROCEDURE

Half-dose photodynamic therapy using verteporfin under the guidance of OCTA

OCTA group
ICGA-guided Photodynamic therapyPROCEDURE

Half-dose photodynamic therapy using verteporfin under the guidance of ICGA

ICGA group

Eligibility Criteria

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

You may qualify if:

  • Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
  • Presence of SRF and/or serous pigment epithelial detachment on OCT
  • Presence of abnormal dilated choroidal vasculature in ICGA

You may not qualify if:

  • Patients with other ocular conditions commonly associated with SRF, such as choroidal neovascularization, polypoidal choroidal vasculopathy (PCV), diabetic retinopathy, retinal vascular occlusion, Coat's disease
  • Any disease that may affect the quality of imaging (quality of OCTA images \< 6), such as cataract, high myopia or nystagmus
  • History of ocular surgeries including retinal laser
  • Pregnancy
  • Any uncontrolled systemic disease
  • Any condition rendering patients intolerable to image acquisition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

  • Hu J, Qu J, Li M, Sun G, Piao Z, Liang Z, Yao Y, Sadda S, Zhao M. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY-GUIDED PHOTODYNAMIC THERAPY FOR ACUTE CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2021 Jan 1;41(1):189-198. doi: 10.1097/IAE.0000000000002795.

    PMID: 32343102DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Mingwei Zhao, M.D

    Peking University People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Ophthalmology, Professor

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 12, 2018

Study Start

September 1, 2017

Primary Completion

December 1, 2017

Study Completion

March 27, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

CN(1)