Different Doses of vPDT in the Treatment of cCSC

NCT05390619 | Unknown DMC

• 1 other identifier: RDL2020-04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Serous Chorioretinopathy; Therapy, Photodynamic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Central foveal thickness change after the PDT

  12 months after the PDT

• Subfoveal choroidal thickness change after the PDT

  12 months after the PDT

• Best corrected visual acuity change after the PDT

  12 months after the PDT

Study Arms (2)

50% dose of PDT

EXPERIMENTAL

Patients received 50% dose of verteporfin PDT therapy.

Procedure: 50% dose of photodynamic therapy

70% dose of PDT

EXPERIMENTAL

Patients received 70% dose of verteporfin PDT therapy.

Procedure: 70% dose of photodynamic therapy

Interventions

50% dose of photodynamic therapy 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.

50% dose of PDT

70% dose of photodynamic therapy 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.

70% dose of PDT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Yuou Yao, Dr

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Yuou Yao, Dr

CONTACT

13651177854; yaoyoyo19@139.com

Mingwei Zhao, Dr

CONTACT

13801057408; dr_mingweizhao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 25, 2022
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

CN (1)