Pseudo-PDT in Central Serous Chorioretinopathy
1 other identifier
interventional
22
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJune 15, 2016
June 1, 2016
3 months
June 6, 2016
June 9, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Best-corrected Visual Acuity (LogMAR)
Measured with ETDRS chart
6 months
Central Retinal Thickness (micron)
Measured with OCT
6 months
Subfoveal Choroidal Thickness (micron)
Measured with OCT
6 months
Secondary Outcomes (1)
Ellipsoid Zone Recovery (integrity of IS/OS line)
6 months
Study Arms (2)
Half Dose Photodynamic Therapy
ACTIVE COMPARATORHalf 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
689 nm Laser Treatment
EXPERIMENTALA 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- any previous treatment for CSC;
- evidence of choroidal neovascularization or other maculopathy on fundus examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD Candidate
Study Record Dates
First Submitted
June 6, 2016
First Posted
June 15, 2016
Study Start
June 1, 2016
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
June 15, 2016
Record last verified: 2016-06