Different Doses of vPDT in the Treatment of cCSC

Sponsor

Peking University People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05390619

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Central Serous Chorioretinopathy Therapy, Photodynamic	Procedure: 50% dose of photodynamic therapy Procedure: 70% dose of photodynamic therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Different Doses of Verteporfin Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50% dose of PDT Patients received 50% dose of verteporfin PDT therapy.	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.
Experimental: 70% dose of PDT Patients received 70% dose of verteporfin PDT therapy.	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.

Arm

Intervention/Treatment

Experimental: 50% dose of PDT

Patients received 50% dose of verteporfin PDT therapy.

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.

Experimental: 70% dose of PDT

Patients received 70% dose of verteporfin PDT therapy.

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.

Outcome Measures

Primary Outcome Measures

The complete absorption rate of subretinal fluid [3 months after the primary PDT]
The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit

Secondary Outcome Measures

Central foveal thickness change after the PDT [12 months after the PDT]
The hight of central foveal thickness was measured on optical coherence tomography at each visit
Subfoveal choroidal thickness change after the PDT [12 months after the PDT]
The hight of Subfoveal choroidal thickness was measured on optical coherence tomography at each visit
Best corrected visual acuity change after the PDT [12 months after the PDT]
The BCVA was tested at each visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University People's Hospital	Beijing	Beijing	China	100044

Sponsors and Collaborators

Peking University People's Hospital

Investigators

Study Chair: Yuou Yao, Dr, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yao Yiou, Principal Investigator, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT05390619

Other Study ID Numbers:

RDL2020-04

First Posted:

May 25, 2022

Last Update Posted:

May 25, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Central Serous Chorioretinopathy

Study Results

No Results Posted as of May 25, 2022