Central Serous Retinopathy (CSR)Phase 1NCT02036632
Eye Patch Therapy for Central Serous Retinopathy (CSR)
A Phase 1 study testing Eye Patching in people with Central Serous Retinopathy (CSR), run by Washington University School of Medicine at 1 site in United States.
Trial summary
First, this study will investigate the viability of 24-hour eye patching as a potential treatment modality for CSR. Second, this study will assess a potential physiologic explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will aid in ameliorating disease severity and disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Serous Retinopathy (CSR)
- What is being tested?
- Eye Patching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jan 2015
- Phase
- Phase 1
- 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
- Adults 18 years of age and older
- Both males and females
- Patients diagnosed with active central serous retinopathy
- Patients who are willing to use an eye patch in the affected eye for 24 hours
- Patients who are able to make the follow up appointments as required by the study
Who cannot join
- Individuals under 18 years of age
- Patients with vision less than 20/40 in the unaffected eye.
- Patients who are not able to undergo mfERG testing in a realiable manner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Universtiy School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Eye Patching as a Potential Treatment Modality for and a Possible Etiological Insight on Central Serous Retinopathy
First, this study will investigate the viability of 24-hour eye patching as a potential treatment modality for CSR. Second, this study will assess a potential physiologic explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will aid in ameliorating disease severity and disease duration.
- Conditions
- Central Serous Retinopathy (CSR)
- Being tested
- Eye Patching
- 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.
Eye PatchingDevice
| Study group | Role | What they receive |
|---|---|---|
| Eye Patching | Other | Intervention Receives: Device: Eye Patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR
This study is a prospective control trial that will compare 24-hour eye patch therapy with the current standard of care in patients with central serous retinopathy (CSR).
Measured: 24 hours
Change in multi-focal ERG response
Measured: 24 hours
Secondary outcomes (1)
macular thickness
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startNov 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous Retinopathy (CSR)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory P Van Stavern, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036632
- Sponsor's protocol ID
- 201211016
- Status last verified
- Jun 2015
- First submitted
- 8 Jan 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Patching as a Potential Treatment Modality for and a Possible Etiological Insight on Central Serous Retinopathy
- ClinicalTrials.gov ID
- NCT02036632
- Acronym / sponsor ID
- 201211016
- Conditions
- Central Serous Retinopathy (CSR)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jan 2014 (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.
First, this study will investigate the viability of 24-hour eye patching as a potential treatment modality for CSR. Second, this study will assess a potential physiologic explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will aid in ameliorating disease severity and disease duration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye Patching | Other | Device: Eye PatchingIntervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years of age and older
- Both males and females
- Patients diagnosed with active central serous retinopathy
- Patients who are willing to use an eye patch in the affected eye for 24 hours
- Patients who are able to make the follow up appointments as required by the study
Key exclusion criteria (3 listed)
- Individuals under 18 years of age
- Patients with vision less than 20/40 in the unaffected eye.
- Patients who are not able to undergo mfERG testing in a realiable manner.
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 |
|---|---|---|
| Eye Patching | Device | Eye Patching |
Primary outcome
Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR
Time frame: 24 hours
This study is a prospective control trial that will compare 24-hour eye patch therapy with the current standard of care in patients with central serous retinopathy (CSR).
Change in multi-focal ERG response
Time frame: 24 hours
1 secondary outcome
macular thickness
Time frame: 24 hours
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 3 Jun 2015.
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.
Gregory P Van Stavern, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eye Patching in people with Central Serous Retinopathy (CSR), run by Washington University School of Medicine at 1 site in United States.
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 3 Jun 2015. 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 United States. 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 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.
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?
Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR (time frame: 24 hours). The study lists 2 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 3 Jun 2015.