Different Doses of vPDT in the Treatment of cCSC

Study Overview
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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.

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

Conditions
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Central Serous Chorioretinopathy, Therapy, Photodynamic

Intervention / Treatment
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* Procedure: 50% dose of photodynamic therapy
* Procedure: 70% dose of photodynamic therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50% dose of PDT<br>Patients received 50% dose of verteporfin PDT therapy. | Procedure: 50% dose of photodynamic therapy<br>* 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.<br>|
| Experimental: 70% dose of PDT<br>Patients received 70% dose of verteporfin PDT therapy. | Procedure: 70% dose of photodynamic therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Best corrected visual acuity change after the PDT | The BCVA was tested at each visit | 12 months after the PDT |