Pseudo-PDT in Central Serous Chorioretinopathy

Università degli Studi di Brescia

Status: Unknown

Conditions: Chronic Central Serous Chorioretinopathy

Treatments: Procedure: Half Dose Photodynamic Therapy; Procedure: 689 nm Laser Treatment of the Macula

Study type: Interventional

Funder types: Other

Identifiers

NCT02799992

CSC0001

Details and patient eligibility

About

Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients, characterized by serous retinal detachment in the macular region. We evaluated half-dose verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.

Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography findings were compared between groups.

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥18 years;
• patients with best-corrected visual acuity (BCVA) of 20/200 or better;
• presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment involving the fovea on optical coherence tomography (OCT);
• presence of active angiographic leakage in fluorescein angiography caused by CSC and no other diseases, and abnormal dilated choroidal vasculature and other features in indocyanine green angiography (ICGA) consistent with the diagnosis of CSC.

Exclusion criteria

• any previous treatment for CSC;
• evidence of choroidal neovascularization or other maculopathy on fundus examination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Half Dose Photodynamic Therapy

Active Comparator group

Description:

Half Dose Photodynamic Therapy The safety enhanced PDT protocol for CSC was performed using half the normal dose of verteporfin (Visudyne, Novartis Pharma, Switzerland), which is 3 mg/m2 verteporfin

Treatment:

Procedure: Half Dose Photodynamic Therapy

689 nm Laser Treatment

Experimental group

Description:

A 689 nm laser treatment delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds was performed. No verteporfin or other drugs were administered to the patients.

Treatment:

Procedure: 689 nm Laser Treatment of the Macula