Central Serous ChorioretinopathyPhase 2NCT00963131
High-dose Antioxidants for Central Serous Chorioretinopathy
A Phase 2 study testing antioxidants tablets in people with Central Serous Chorioretinopathy, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually involves the macular area. It is common in patients between 30-50 years old and effects male more often than female with the ratio of 5-10. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- antioxidants tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2004to Jun 2009
- Phase
- Phase 2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with acute central serous chorioretinopathy within 6 weeks of onset
- age between 30-50 years
- new or recurrent attack (the symptom-free period should longer than 6 months)
- fluorescein angiography (FA) confirmed the diagnosis with the inkblot or smoke-stack leakage and the optical coherence tomography (OCT) showed definite subretinal fluid
- patients' ability for proper follow up.
Who cannot join
- chronic central serous chorioretinopathy(longer than 6 weeks)
- complicated central serous chorioretinopathy such as secondary choroidal neovascularization (CNV) that detected from FA
- pregnancy, steroid user and patients that contraindicated for high dose antioxidants therapy such as heavy smokers, lung cancer, thyrotoxicosis, renal stone and anemia (hematocrit less than 30%).
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Ophthalmology, Faculty of medicine, Prince of Songkla university
Hat Yai, Changwat Songkhla, 90110
About this study
Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually involves the macular area. It is common in patients between 30-50 years old and effects male more often than female with the ratio of 5-10. The common risk factors are psychologic stress, type A personality, systemic steroid use, hypertension and pregnancy. The treatment is usually observation especially in the first three-months. The laser or photodynamic therapy should be considered when the condition does not improve after that time. Nevertheless, the pathogenesis of CSC is still not well understood but the study from indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal leakage. The causes of this abnormality are supposed to be from nitric oxide, prostaglandins or even free oxidative radicals. From this hypothesis, the oxidative process might be involved in the pathogenesis of the disease especially in the early stage. This study is to determine the effect of antioxidants drugs in the acute stage of CSC and to determine whether they can improve the outcomes of the disease.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- antioxidants tablets
- Keywords
- Central serous chorioretinopathy,antioxidants
- 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.
antioxidants tabletsDrug
Also called Icaps
vitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms.
| Study group | Role | What they receive |
|---|---|---|
| antioxidant tablets | Experimental | the study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease Receives: Drug: antioxidants tablets |
| placebo tablets | Placebo comparator | the control arm received placebo tablets for 3 months or until the resolution of the disease Receives: Drug: antioxidants tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity and central macular thickness
Measured: 6 months
Secondary outcomes (1)
fluorescein leakage at the third month
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 posted21 Aug 2009 (estimated)
- Study startDec 2004
- Primary completionDec 2008
- Study completionJun 2009
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Mansing - Ratnasukon, MD, Principal investigator, Department of Ophthalmology, Faculty of medicine, Prince of Songkla university, Hat yai, Songkhla province, Thailand 90110
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963131
- Sponsor's protocol ID
- EC 47/362-023
- Other IDs
- PSU 2547
- Status last verified
- Dec 2009
- First submitted
- 20 Aug 2009
- Last updated
- 30 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
PubMed 40522203
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Antioxidants for Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT00963131
- Acronym / sponsor ID
- EC 47/362-023
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Central serous chorioretinopathy,antioxidants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Dec 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Aug 2009 (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.
Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually involves the macular area. It is common in patients between 30-50 years old and effects male more often than female with the ratio of 5-10. The common risk factors are psychologic stress, type A personality, systemic steroid use, hypertension and pregnancy. The treatment is usually observation especially in the first three-months. The laser or photodynamic therapy should be considered when the condition does not improve after that time. Nevertheless, the pathogenesis of CSC is still not well understood but the study from indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal leakage. The causes of this abnormality are supposed to be from nitric oxide, prostaglandins or even free oxidative radicals. From this hypothesis, the oxidative process might be involved in the pathogenesis of the disease especially in the early stage. This study is to determine the effect of antioxidants drugs in the acute stage of CSC and to determine whether they can improve the outcomes of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antioxidant tablets | Experimental | Drug: antioxidants tabletsthe study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease |
| placebo tablets | Placebo comparator | Drug: antioxidants tabletsthe control arm received placebo tablets for 3 months or until the resolution of the disease |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients with acute central serous chorioretinopathy within 6 weeks of onset
- age between 30-50 years
- new or recurrent attack (the symptom-free period should longer than 6 months)
- fluorescein angiography (FA) confirmed the diagnosis with the inkblot or smoke-stack leakage and the optical coherence tomography (OCT) showed definite subretinal fluid
- patients' ability for proper follow up.
Key exclusion criteria (3 listed)
- chronic central serous chorioretinopathy(longer than 6 weeks)
- complicated central serous chorioretinopathy such as secondary choroidal neovascularization (CNV) that detected from FA
- pregnancy, steroid user and patients that contraindicated for high dose antioxidants therapy such as heavy smokers, lung cancer, thyrotoxicosis, renal stone and anemia (hematocrit less than 30%).
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 |
|---|---|---|
| antioxidants tabletsAlso: Icapsvitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms. | Drug | antioxidant tablets, placebo tablets |
Primary outcome
visual acuity and central macular thickness
Time frame: 6 months
1 secondary outcome
fluorescein leakage at the third month
Time frame: 6 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 30 Dec 2009.
- Derived from this study: PubMed 40522203Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
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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.
Mansing - Ratnasukon, MD principal investigator
Department of Ophthalmology, Faculty of medicine, Prince of Songkla university, Hat yai, Songkhla province, Thailand 90110
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing antioxidants tablets in people with Central Serous Chorioretinopathy, run by Prince of Songkla University at 1 site in Thailand.
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 5 inclusion and 3 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 30 Dec 2009. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
visual acuity and central macular thickness (time frame: 6 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 NCT00963131, 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 30 Dec 2009.