Chronic Central Serous ChorioretinopathyNCT02799992
Pseudo-PDT in Central Serous Chorioretinopathy
A study testing 689 nm Laser Treatment of the Macula and Half Dose Photodynamic Therapy in people with Chronic Central Serous Chorioretinopathy, run by Università degli Studi di Brescia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Central Serous Chorioretinopathy
- What is being tested?
- 689 nm Laser Treatment of the Macula and Half Dose Photodynamic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- any previous treatment for CSC;
- evidence of choroidal neovascularization or other maculopathy on fundus examination.
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- 689 nm Laser Treatment of the Macula, Half Dose Photodynamic Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
689 nm Laser Treatment of the MaculaProcedure or surgery
Half Dose Photodynamic TherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Half Dose Photodynamic Therapy | Active comparator | 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 Receives: Procedure: Half Dose Photodynamic Therapy |
| 689 nm Laser Treatment | Experimental | 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. Receives: Procedure: 689 nm Laser Treatment of the Macula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected Visual Acuity (LogMAR)
Measured with ETDRS chart
Measured: 6 months
Central Retinal Thickness (micron)
Measured with OCT
Measured: 6 months
Subfoveal Choroidal Thickness (micron)
Measured with OCT
Measured: 6 months
Secondary outcomes (1)
Ellipsoid Zone Recovery (integrity of IS/OS line)
As visible with OCT scans
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Russo, Università degli Studi di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799992
- Sponsor's protocol ID
- CSC0001
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudo-PDT in Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT02799992
- Acronym / sponsor ID
- CSC0001
- Conditions
- Chronic Central Serous Chorioretinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Half Dose Photodynamic Therapy | Active comparator | Procedure: Half Dose Photodynamic TherapyHalf 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 | Experimental | Procedure: 689 nm Laser Treatment of the MaculaA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- any previous treatment for CSC;
- evidence of choroidal neovascularization or other maculopathy on fundus examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 689 nm Laser Treatment of the Macula | Procedure or surgery | 689 nm Laser Treatment |
| Half Dose Photodynamic Therapy | Procedure or surgery | Half Dose Photodynamic Therapy |
Primary outcome
Best-corrected Visual Acuity (LogMAR)
Time frame: 6 months
Measured with ETDRS chart
Central Retinal Thickness (micron)
Time frame: 6 months
Measured with OCT
Subfoveal Choroidal Thickness (micron)
Time frame: 6 months
Measured with OCT
1 secondary outcome
Ellipsoid Zone Recovery (integrity of IS/OS line)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing 689 nm Laser Treatment of the Macula and Half Dose Photodynamic Therapy in people with Chronic Central Serous Chorioretinopathy, run by Università degli Studi di Brescia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Russo, MD, PhD (+390303995308, dott.andrea.russo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected Visual Acuity (LogMAR) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2016.