Different Doses of vPDT in the Treatment of cCSC

NCT05390619 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-25

No results posted yet for this study

Summary

This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. The primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (OCT), and then the best PDT treatment scheme for chronic CSC was summarized.

Conditions

  • Central Serous Chorioretinopathy
  • Therapy, Photodynamic

Interventions

PROCEDURE

50% dose of photodynamic therapy

Verteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 50% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2.

PROCEDURE

70% dose of photodynamic therapy

Verteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 70% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Yuou Yao, Dr · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05390619 on ClinicalTrials.gov