Central Serous ChorioretinopathyNCT03497000
Effects of OCTA-guided PDT in Acute CSC
A study testing OCTA-guided Photodynamic therapy and ICGA-guided Photodynamic therapy in people with Central Serous Chorioretinopathy and Tomography, Optical Coherence, run by Peking University People's Hospital at 1 site in China.
Trial summary
OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Central Serous Chorioretinopathy, Tomography, Optical Coherence
- What is being tested?
- OCTA-guided Photodynamic therapy and ICGA-guided Photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 27 Mar 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
- Presence of SRF and/or serous pigment epithelial detachment on OCT
- Presence of abnormal dilated choroidal vasculature in ICGA
Who cannot join
- Patients with other ocular conditions commonly associated with SRF, such as choroidal neovascularization, polypoidal choroidal vasculopathy (PCV), diabetic retinopathy, retinal vascular occlusion, Coat's disease
- Any disease that may affect the quality of imaging (quality of OCTA images < 6), such as cataract, high myopia or nystagmus
- History of ocular surgeries including retinal laser
- Pregnancy
- Any uncontrolled systemic disease
- Any condition rendering patients intolerable to image acquisition
Trial locations and contacts
1 site in 1 country.
China1 site
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
About this study
Official title: Effects of Optical Coherence Tomography Angiography-guided Photodynamic Therapy in Acute Central Serous Chorioretinopathy
OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well.
- Being tested
- OCTA-guided Photodynamic therapy, ICGA-guided Photodynamic therapy
- Keywords
- optical coherence tomography angiography, central serous chorioretinopathy, photodynamic therapy
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTA-guided Photodynamic therapyProcedure or surgery
Half-dose photodynamic therapy using verteporfin under the guidance of OCTA
ICGA-guided Photodynamic therapyProcedure or surgery
Half-dose photodynamic therapy using verteporfin under the guidance of ICGA
| Study group | Role | What they receive |
|---|---|---|
| OCTA group | Experimental | Patients in this group underwent OCTA-guided half-dose photodynamic therapy. Receives: Procedure: OCTA-guided Photodynamic therapy |
| ICGA group | Active comparator | Patients in this group underwent normal ICGA-guided half dose photodynamic therapy. Receives: Procedure: ICGA-guided Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with subretinal fluid resolution on OCT after PDT of two groups
Measured: 3 months
Secondary outcomes (3)
Number of patients with leakage point resolution on FFA after PDT of two groups
Measured: 3 months
Number of recurrent CSC after PDT of two groups
Measured: 3 months
BCVA (best corrected visual acuity) at every follow-up of two groups
Measured: 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Sep 2017
- Primary completion1 Dec 2017
- Study completion27 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Mingwei Zhao, Peking University People's Hospital
- Investigators
- Mingwei Zhao, M.D, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497000
- Sponsor's protocol ID
- Peking UPH
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hu J, Qu J, Li M, Sun G, Piao Z, Liang Z, Yao Y, Sadda S, Zhao M. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY-GUIDED PHOTODYNAMIC THERAPY FOR ACUTE CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2021 Jan 1;41(1):189-198. doi: 10.1097/IAE.0000000000002795.
PubMed 32343102
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Optical Coherence Tomography Angiography-guided Photodynamic Therapy in Acute Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT03497000
- Acronym / sponsor ID
- Peking UPH
- Keywords
- optical coherence tomography angiography, central serous chorioretinopathy, photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 27 Mar 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- 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.
OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCTA group | Experimental | Procedure: OCTA-guided Photodynamic therapyPatients in this group underwent OCTA-guided half-dose photodynamic therapy. |
| ICGA group | Active comparator | Procedure: ICGA-guided Photodynamic therapyPatients in this group underwent normal ICGA-guided half dose photodynamic therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
- Presence of SRF and/or serous pigment epithelial detachment on OCT
- Presence of abnormal dilated choroidal vasculature in ICGA
Key exclusion criteria (6 listed)
- Patients with other ocular conditions commonly associated with SRF, such as choroidal neovascularization, polypoidal choroidal vasculopathy (PCV), diabetic retinopathy, retinal vascular occlusion, Coat's disease
- Any disease that may affect the quality of imaging (quality of OCTA images < 6), such as cataract, high myopia or nystagmus
- History of ocular surgeries including retinal laser
- Pregnancy
- Any uncontrolled systemic disease
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 |
|---|---|---|
| OCTA-guided Photodynamic therapyHalf-dose photodynamic therapy using verteporfin under the guidance of OCTA | Procedure or surgery | OCTA group |
| ICGA-guided Photodynamic therapyHalf-dose photodynamic therapy using verteporfin under the guidance of ICGA | Procedure or surgery | ICGA group |
Primary outcome
Number of patients with subretinal fluid resolution on OCT after PDT of two groups
Time frame: 3 months
3 secondary outcomes
Number of patients with leakage point resolution on FFA after PDT of two groups
Time frame: 3 months
Number of recurrent CSC after PDT of two groups
Time frame: 3 months
BCVA (best corrected visual acuity) at every follow-up of two groups
Time frame: 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 32343102Hu J, Qu J, Li M, Sun G, Piao Z, Liang Z, Yao Y, Sadda S, Zhao M. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY-GUIDED PHOTODYNAMIC THERAPY FOR ACUTE CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2021 Jan 1;41(1):189-198. doi: 10.1097/IAE.0000000000002795.
- Individual participant dataSharing planned: Undecided
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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.
Mingwei Zhao, M.D study director
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCTA-guided Photodynamic therapy and ICGA-guided Photodynamic therapy in people with Central Serous Chorioretinopathy and Tomography, Optical Coherence, run by Peking University People's Hospital at 1 site in China.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with subretinal fluid resolution on OCT after PDT of two groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03497000, which also lists 1 linked publication.
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 17 Apr 2018.