Pseudo-PDT in Central Serous Chorioretinopathy

NCT ID: NCT02799992

Last Updated: 2016-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2016-09-30

Brief Summary

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.

Conditions

Chronic Central Serous Chorioretinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Half Dose Photodynamic Therapy

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

Group Type: ACTIVE_COMPARATOR

Half Dose Photodynamic Therapy

Intervention Type: PROCEDURE

689 nm Laser Treatment

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.

Group Type: EXPERIMENTAL

689 nm Laser Treatment of the Macula

Intervention Type: PROCEDURE

Interventions

689 nm Laser Treatment of the Macula

Intervention Type: PROCEDURE

Half Dose Photodynamic Therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Russo

MD, PhD Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Andrea Russo, MD, PhD

Role: CONTACT

dott.andrea.russo@gmail.com

+390303995308

Other Identifiers

CSC0001

Identifier Type: -

Identifier Source: org_study_id