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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05390619
Other study ID # RDL2020-04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2023

Study information

Verified date May 2022
Source Peking University People's Hospital
Contact Yuou Yao, Dr
Phone 13651177854
Email yaoyoyo19@139.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

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.
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.

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The complete absorption rate of subretinal fluid The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit 3 months after the primary PDT
Secondary Central foveal thickness change after the PDT The hight of central foveal thickness was measured on optical coherence tomography at each visit 12 months after the PDT
Secondary Subfoveal choroidal thickness change after the PDT The hight of Subfoveal choroidal thickness was measured on optical coherence tomography at each visit 12 months after the PDT
Secondary Best corrected visual acuity change after the PDT The BCVA was tested at each visit 12 months after the PDT
See also
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