Different Doses of vPDT in the Treatment of cCSC

NCT ID: NCT05390619

Last Updated: 2022-05-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Central Serous Chorioretinopathy Therapy, Photodynamic

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 of PDT

Patients received 50% dose of verteporfin PDT therapy.

Group Type EXPERIMENTAL

50% dose of photodynamic therapy

Intervention Type PROCEDURE

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.

70% dose of PDT

Patients received 70% dose of verteporfin PDT therapy.

Group Type EXPERIMENTAL

70% dose of photodynamic therapy

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18-75 years old, regardless of gender;
* Meet the diagnostic criteria of central serous chorioretinopathy;
* The course of CSC (subject to the symptoms of this disease) is more than 3 months;
* Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.

Exclusion Criteria

* macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases;
* a previous history of PDT treatment;
* systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Yao Yiou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuou Yao, Dr

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuou Yao, Dr

Role: CONTACT

13651177854

Mingwei Zhao, Dr

Role: CONTACT

13801057408

Facility Contacts

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Yuou Yao, Dr

Role: primary

Other Identifiers

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RDL2020-04

Identifier Type: -

Identifier Source: org_study_id

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