Central Serous ChorioretinopathyPhase 1/2ICSCRNCT00817245
Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR)
A Phase 1/2 study testing omeprazole, Amoxicillin, metronidazole in people with Central Serous Chorioretinopathy, run by Tabriz University at 1 site in Iran.
Trial summary
Etiology of ICSCR is not known however recent studies regard the role of immunologic and infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have positive effect on the remission of ICSCR. Read more about this study
- Who is it for?
- Ages 28 to 40 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- omeprazole, Amoxicillin, metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- Mar 2008to Jan 2009
- Phase
- Phase 1/2
- 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 28 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- the persons who are infected with helicobacter pylori and have ICSCR
Who cannot join
- history of previous eye surgery ,to have indication of laser therapy,corticosteroid therapy,pregnancy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Helicobacter Pylori Treatment on Remission of Idiopathic Central Serous Chorioretinopathy (ICSCR)
Etiology of ICSCR is not known however recent studies regard the role of immunologic and infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have positive effect on the remission of ICSCR.
Read the detailed description
we will choose 50 cases of patients with ICSCR who are infected with h.pylori.25 cases will receive anti h.pylori regiment and 25 cases as controls will receive no medication.then we will compare the time of submacular fluid resorption and macular thickness and visual acuity among these two groups.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- omeprazole, Amoxicillin, metronidazole
- Keywords
- CSR, Helicobacter pylori
- 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.
omeprazole, Amoxicillin, metronidazoleDrug
Also called treatment of Central serous chorioretinopathy
we will evaluate the effect of medication(anti h.pylori) on the remission of ICSCR
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oral Amoxicillin Capsule Metronidazole Tablet Omeprazole Capsule Receives: Drug: omeprazole, Amoxicillin, metronidazole |
| 2 | No intervention | No medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subretinal fluid level
Secondary outcomes (1)
time of sub macular fluid absorption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionJan 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- Alireza Javadzadeh, Study chair, Alireza Javadzadeh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817245
- Sponsor's protocol ID
- 86-47
- Acronym
- ICSCR
- Status last verified
- Jan 2009
- First submitted
- 1 Jan 2009
- Last updated
- 6 Jan 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 6 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Helicobacter Pylori Treatment on Remission of Idiopathic Central Serous Chorioretinopathy (ICSCR)
- ClinicalTrials.gov ID
- NCT00817245
- Acronym / sponsor ID
- ICSCR / 86-47
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- CSR, Helicobacter pylori
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 6 Jan 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.
Etiology of ICSCR is not known however recent studies regard the role of immunologic and infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have positive effect on the remission of ICSCR.
Detailed description
we will choose 50 cases of patients with ICSCR who are infected with h.pylori.25 cases will receive anti h.pylori regiment and 25 cases as controls will receive no medication.then we will compare the time of submacular fluid resorption and macular thickness and visual acuity among these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: omeprazole, Amoxicillin, metronidazoleOral Amoxicillin Capsule Metronidazole Tablet Omeprazole Capsule |
| 2 | No intervention | –No medical treatment |
Who may qualify
- Ages
- 28 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- the persons who are infected with helicobacter pylori and have ICSCR
Key exclusion criteria (1 listed)
- history of previous eye surgery ,to have indication of laser therapy,corticosteroid therapy,pregnancy,
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 |
|---|---|---|
| omeprazole, Amoxicillin, metronidazoleAlso: treatment of Central serous chorioretinopathywe will evaluate the effect of medication(anti h.pylori) on the remission of ICSCR | Drug | 1 |
Primary outcome
Subretinal fluid level
1 secondary outcome
time of sub macular fluid absorption
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 6 Jan 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.
Alireza Javadzadeh study chair
Alireza Javadzadeh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing omeprazole, Amoxicillin, metronidazole in people with Central Serous Chorioretinopathy, run by Tabriz University at 1 site in Iran.
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 1 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 6 Jan 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 Iran. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Subretinal fluid level. 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 NCT00817245, 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 6 Jan 2009.