Reduced-fluence Photodynamic Therapy versus Placebo for Central Serous Chorioretinopathy

JRCT ID: jRCT2051230156

Registered date:26/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: central serous chorioretinopathy
• Date of first enrollment: 26/12/2023
• Target sample size: 70
• Study type: Interventional
• Intervention(s): reduced-fluence photodynamic therapy

Outcome(s)

• Primary Outcome: The percentage of patients in whom central macular detachment resolved within 12 weeks of treatment.

Secondary Outcome

The percentage of patients in whom central macular detachment has disappeared at 24, 36, and 48 weeks after treatment.
The percentage of patients at 12, 24, 36, and 48 weeks after treatment whose vision has either remained stable or improved.
The number of readable characters on the ETDRS visual acuity test at 48 weeks after treatment.
LogMAR (logarithm of the minimum angle of resolution) based on decimal visual acuity testing at 12, 24, 36, and 48 weeks after treatment.
Duration until the disappearance of central macular detachment.
Height and extent of central macular detachment.
Subfoveal choroidal thickness.
Incidence rate of macular neovascularization.
Rate of recurrence after the disappearance of central macular detachment.
Frequency of adverse events and side effects.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

Patients meeting all of the following criteria will be included:
1) Patients diagnosed with chronic central serous chorioretinopathy (CSC) by optical cpherence tomography (OCT), fluoreceine angiography/Indocyanine green angiography (FA/ICGA), or fundus autofluoresence (FAF).
2) Estimated onset date (or estimated recurrence date for the previously treated cohort) is more than 3 months prior to registration based on results such as interviews and has not exceeded 12 months.
3) Retinal detachment involving the fovea in only one eye confirmed in pre-registration examinations.
4) Untreated cohort: Patients who have not received PDT.
Previously treated cohort: Patients who have previously received PDT for chronic CSC and have experienced a recurrence.
5) Age at the time of obtaining consent is between 18 and less than 70 years.
6) Written consent for trial participation has been obtained from the patient personally.

Exclude criteria

Exclude individuals who meet any of the following criteria:

Study eye (eye with serous retinal detachment of fovea):
1.1) Best-corrected visual acuity less than 0.1.
1.2) Untreated Cohort: Individuals who have received treatment for the macular region through retinal photocoagulation, PDT, or anti-VEGF agents.
Previously treated cohort: Individuals who have received treatment for the macular region through retinal photocoagulation or anti-VEGF agents.
1.3) Presence of cystoid macular edema or advanced choroidal atrophy involving the macula.
1.4) Individuals with age-related macular degeneration, myopic choroidal neovascularization, angioid streaks, inferior posterior staphyloma, severe glaucoma, or other conditions believed to affect visual acuity.
1.5) Spherical equivalent less than -6 diopters or axial length greater than 26.5mm, indicating severe myopia.
1.6) History of intraocular surgery other than cataract surgery.
1.7) Difficulty in examine the fundus of the eye.

Fellow eye of the study eye:
2.1) Best-corrected visual acuity less than 0.1.

Other:
3.1) Individuals receiving continuous systemic administration of steroids.
3.2) Individuals with severe infections and other severe complications (systemic debilitation, severe diabetes, severe heart disease, severe cerebrovascular disease, cirrhosis, pheochromocytoma, porphyria, ongoing malignant tumors).
3.3) Individuals with a history of severe drug allergies to fluorescein angiography agents (fluorescein, indocyanine green, etc.), verteporfin, mydriatics (tropicamide, etc.), iodine, and others.
3.4) Women who are pregnant or may be pregnant. Women who are breastfeeding. Women who do not agree to use appropriate contraception from the time of obtaining consent until the end of the trial.
3.5) Individuals who have participated in other clinical studies or trials involving interventions within the last 6 months before obtaining consent.
3.6) Other cases where the Principal Investigator or responsible physician deems participation in the trial to be inappropriate.

Related Information

• Primary Sponsor: Miyake Masahiro