Chronic Central Serous ChorioretinopathyNCT01434095
Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
A study testing half-dose photodynamic therapy in people with Chronic Central Serous Chorioretinopathy, run by Surugadai Nihon University Hospital at 1 site in Japan.
Trial summary
A half-dose photodynamic therapy, a relative new treatment, has been widely performed to treat central serous chorioretinopathy. The researchers aimed to investigate whether the therapy improved the patient's visual acuity as well as the retinal sensitivity. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Chronic Central Serous Chorioretinopathy
- What is being tested?
- half-dose photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2008to Jul 2010
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of subretinal fluid involving the fovea in the Optical coherence tomographic (OCT) images
- a serous retinal detachment of at least 6 months duration.
Who cannot join
- evidence of a choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or Indocyanine green angiography
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Ophthalmology, Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, 101-8309
About this study
A half-dose photodynamic therapy, a relative new treatment, has been widely performed to treat central serous chorioretinopathy.
The researchers aimed to investigate whether the therapy improved the patient's visual acuity as well as the retinal sensitivity. The researchers also investigate which clinical factors, if any, were associated with the results; visual acuity or retinal sensitivity after the treatment.
Read the detailed description
The best-corrected visual acuity (BCVA), macular sensitivity, and fixation stability were evaluated at the baseline and at 1, 3, 6, and 12 months after the half-dose photodynamic therapy. The macular sensitivity and fixation stability were determined by MP-1 microperimetry (Nidek, Vigonza, Italy). The researchers analysed whether the BCVA and retinal sensitivity significantly improved or not. And if yes, the researchers were interested at which period after treatment the significant improvement was found. Also, the researchers investigated which improved first, BCVA or retinal sensitivity.
- Conditions
- Chronic Central Serous Chorioretinopathy
- Being tested
- half-dose photodynamic therapy
- Keywords
- microperimetry, fixation point, retinal sensitivity, photodynamic therapy, chronic central serous chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
half-dose photodynamic therapyProcedure or surgery
photodynamic therapy (PDT) was performed using 3 mg/m2 body surface area of verteporfin (Visudyne, Novartis AG, Bülach, Switzerland) which is one-half the conventional dose of verteporfin. The verteporfin was infused over a 10 minute period followed by the delivery of 50 J/cm2 from a 689-nm laser system (Carl Zeiss, Dublin, CA) over an 83-second exposure time.
| Study group | Role | What they receive |
|---|---|---|
| half-dose PDT(photodynamic therapy) | Active comparator | The study include single arm; treated group, and no control group was included. Receives: Procedure: half-dose photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
Measured: one year
Secondary outcomes (1)
retinal sensitivity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startOct 2008
- Primary completionJul 2010
- Study completionJul 2010
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surugadai Nihon University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Teikyo University
- Responsible party
- Principal investigator, Kyoko Fujita, Surugadai Nihon University Hospital
- Investigators
- Kyoko Fujita, MD, PhD, Principal investigator, Department of Ophthalmology, Surugadai Nihon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434095
- Sponsor's protocol ID
- 81004
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2011
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Fujita K, Shinoda K, Imamura Y, Matsumoto CS, Mizutani Y, Mizota A, Yuzawa M. Correlation of integrity of cone outer segment tips line with retinal sensitivity after half-dose photodynamic therapy for chronic central serous chorioretinopathy. Am J Ophthalmol. 2012 Sep;154(3):579-85. doi: 10.1016/j.ajo.2012.03.043. Epub 2012 Jul 20.
PubMed 22818904
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT01434095
- Acronym / sponsor ID
- 81004
- Conditions
- Chronic Central Serous Chorioretinopathy
- Keywords
- microperimetry, fixation point, retinal sensitivity, photodynamic therapy, chronic central serous chorioretinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Surugadai Nihon University HospitalUniversity, hospital or other
- Collaborators
- Teikyo University
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Sep 2011 (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.
A half-dose photodynamic therapy, a relative new treatment, has been widely performed to treat central serous chorioretinopathy.
The researchers aimed to investigate whether the therapy improved the patient's visual acuity as well as the retinal sensitivity. The researchers also investigate which clinical factors, if any, were associated with the results; visual acuity or retinal sensitivity after the treatment.
Detailed description
The best-corrected visual acuity (BCVA), macular sensitivity, and fixation stability were evaluated at the baseline and at 1, 3, 6, and 12 months after the half-dose photodynamic therapy. The macular sensitivity and fixation stability were determined by MP-1 microperimetry (Nidek, Vigonza, Italy). The researchers analysed whether the BCVA and retinal sensitivity significantly improved or not. And if yes, the researchers were interested at which period after treatment the significant improvement was found. Also, the researchers investigated which improved first, BCVA or retinal sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| half-dose PDT(photodynamic therapy) | Active comparator | Procedure: half-dose photodynamic therapyThe study include single arm; treated group, and no control group was included. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the presence of subretinal fluid involving the fovea in the Optical coherence tomographic (OCT) images
- a serous retinal detachment of at least 6 months duration.
Key exclusion criteria (1 listed)
- evidence of a choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or Indocyanine green angiography
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 |
|---|---|---|
| half-dose photodynamic therapyphotodynamic therapy (PDT) was performed using 3 mg/m2 body surface area of verteporfin (Visudyne, Novartis AG, Bülach, Switzerland) which is one-half the conventional dose of verteporfin. The verteporfin was infused over a 10 minute period followed by the delivery of 50 J/cm2 from a 689-nm laser system (Carl Zeiss, Dublin, CA) over an 83-second exposure time. | Procedure or surgery | half-dose PDT(photodynamic therapy) |
Primary outcome
best corrected visual acuity
Time frame: one year
1 secondary outcome
retinal sensitivity
Time frame: one year
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 15 Sep 2011.
- Derived from this study: PubMed 22818904Fujita K, Shinoda K, Imamura Y, Matsumoto CS, Mizutani Y, Mizota A, Yuzawa M. Correlation of integrity of cone outer segment tips line with retinal sensitivity after half-dose photodynamic therapy for chronic central serous chorioretinopathy. Am J Ophthalmol. 2012 Sep;154(3):579-85. doi: 10.1016/j.ajo.2012.03.043. Epub 2012 Jul 20.
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.
Kyoko Fujita, MD, PhD principal investigator
Department of Ophthalmology, Surugadai Nihon University 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 half-dose photodynamic therapy in people with Chronic Central Serous Chorioretinopathy, run by Surugadai Nihon University Hospital at 1 site in Japan.
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 2 inclusion and 1 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 15 Sep 2011. 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 Japan. 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?
best corrected visual acuity (time frame: one year). 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 NCT01434095, 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 15 Sep 2011; AzTrials last refreshed its copy on 31 Oct 2026.