Central Serous ChorioretinopathyPhase 2STOMP-CSCNCT02354170
Short-Term Oral Mifepristone for Central Serous Chorioretinopathy
A Phase 2 study testing Mifepristone in people with Central Serous Chorioretinopathy, run by Roger Goldberg, M.D., MBA at 2 sites in United States.
Trial summary
The goal of the study is to assess the efficacy and safety of mifepristone 300 or 900-mg once-daily dosing by mouth for 4 weeks in patients with central serous chorioretinopathy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2015to 27 Apr 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of central serous chorioretinopathy (CSC) with symptoms 6 weeks or prior documented episodes of sub-retinal fluid; patients who have had previous treatment for CSC may be included
- Presence of sub-retinal fluid as documented on optical coherence tomography (OCT) in the central foveal sub-field
- Age 18 or over
- Willing and able to comply with clinic visits and study-related procedures
- Ability to give written informed consent
Who cannot join
- Age less than 18
- Persons with impaired decision-making ability.
- Women who are known to be breast-feeding, pregnant or are actively trying to conceive.
- Additional eye disease affecting the macula, posterior retina, or ocular media that would limit or prevent the acquisition of OCT and angiographic images.
- At screening, serum potassium < LLN, BUN > 1.5 ULN, serum creatinine >1.5 ULN, AST > 1.5 ULN, ALT >1.5 ULN, bilirubin > 1.5 ULN, alkaline phosphatase > 1.5 ULN, serum albumin >1.5 ULN or <LLN.
- Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
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- Active intraocular inflammation (grade trace or above) in the study eye.
- Patients taking simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus.
- Patients who require concomitant treatment with systemic corticosteroids for serious medical conditions or illnesses (e.g., immunosuppression after organ transplantation).
- Women with a history of unexplained vaginal bleeding and women with endometrial hyperplasia with atypia or endometrial carcinoma.
- Patients with prior hypersensitivity reactions to mifepristone or to any of the product components.
- Patients with known hypersensitivity to fluorescein or indocyanine green dyes.
- WOCBP must be willing to practice adequate contraception during the study (adequate contraceptive measures include intrauterine device [IUD]; bilateral tubal ligation; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly). Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Bay Area Retina Associates
Walnut Creek, California, 94598
About this study
Official title: Short-Term Oral Mifepristone for Central Serous Chorioretinopathy. A Placebo-controlled Dose Ranging Study of Mifepristone in the Treatment of CSC (STOMP-CSC)
The goal of the study is to assess the efficacy and safety of mifepristone 300 or 900-mg once-daily dosing by mouth for 4 weeks in patients with central serous chorioretinopathy.
Read the detailed description
- Prospective, randomized, double-masked, placebo-controlled dose-ranging study
- Eligible patients will be those with CSC, with symptoms of blurred or distorted vision, with the presence of sub-retinal fluid as documented on optical coherence tomography (OCT) in the central foveal sub-field
- Only one eye of a participant will be included in the study, although both eyes will be evaluated. In patients with bilateral CSC, the eye with more sub-foveal fluid on OCT will be the study eye.
- Patients will be evaluated and treated at one of two study centers:
Ophthalmic Consultants of Boston (OCB), 50 Staniford St., Suite 600, Boston, MA
Bay Area Retina Associates (BARA), 122 La Casa Via, Suite 223, Walnut Creek, CA
- All participants will receive a standard ophthalmic examination as well as fluorescein and indocyanine green angiography and macular OCT per protocol.
- 30 patients will be enrolled, as follows: 10 patients will be randomly assigned to Cohort 1, and will take one (1) mifepristone 300-mg tablet (300 mg total dose) once daily by mouth for 4 weeks. 10 patients will be randomly assigned to Cohort 2, and will take three (3) mifepristone 300-mg tablet (900 mg total dose) once daily by mouth for 4 weeks. 10 patients will be randomly assigned to Cohort 3, and will take placebo tablet(s) once daily by mouth for 4 weeks.
- After completing the enrollment criteria, a subject will be randomized 1:1:1 to Cohort 1, 2, or 3.
- During the Baseline visit and at the Week 2, 4, and 8 visits, all subjects will have laboratory testing of the following lab tests: serum electrolytes, BUN and creatinine, liver function tests
- Prior to initiating dosing of the study drug, all women of child-bearing potential (WOCBP) will have a serum beta-HCG assessed to rule out pregnancy; all WOCBP who are enrolled in the study will be required to use barrier contraception throughout the study.
- Adverse events will be tracked at each visit (see "Data Safety and Monitoring Plan" below)
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Mifepristone, Placebo
- Keywords
- Central Serous Chorioretinopathy, CSC
- 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.
MifepristoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (m300) | Experimental | One (1) 300-mg mifepristone tablet, taken once daily for 4 weeks Receives: Drug: Mifepristone |
| Cohort 2 (m900) | Experimental | Three (3) 300-mg mifepristone tablets (900-mg dose), taken once daily for 4 weeks Receives: Drug: Mifepristone |
| Cohort 3 (Placebo) | Placebo comparator | Placebo taken once daily for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Sub-retinal Fluid
Presence or absence of subretinal fluid on spectral-domain OCT after 4 weeks of treatment with mifepristone 300 or 900 mg daily, compared with placebo.
Measured: 4 weeks after treatment
Secondary outcomes (9)
Change in sub-retinal fluid and/or intraretinal fluid
Change compared to Baseline in subretinal fluid and/or intraretinal fluid on OCT at Week 1, 2, 4, and 8,
Measured: Week 1, 2, 4, and 8
Best Corrected Visual Acuity
Change compared to Baseline in ETDRS BCVA at Week 1, 2, 4, and 8.
Measured: Week 1, 2, 4, and 8
Change in macular thickness
Change compared to Baseline in central macular circle thickness on OCT, automatically calculated with OCT software at Week 1, 2, 4, and 8.
Measured: Week 1, 2, 4, and 8
Change in foveal thickness
Change compared to Baseline in thickness of subretinal fluid under the fovea on OCT, manually calculated at Week 1, 2, 4, and 8
Measured: Week 1, 2, 4, and 8
Change in choroidal thickness
Change compared to Baseline in thickness of choroid under the fovea on enhanced-depth imaging OCT, manually calculated, at Week 1, 2, 4, and 8.
Measured: Week 1, 2, 4, and 8
Dye leakage in vasculature
Change compared to Baseline in dye leakage characteristics on fluorescein and indocyanine green angiography at Week 4 and Week 8.
Measured: Week 4 and 8
Change in OCT characteristics in the fellow eye
Change compared to Baseline in the same OCT characteristics listed above, in the fellow eye.
Measured: Week 8
Proportion of acute vs. chronic CSC patients
Proportion of acute versus chronic CSC patients as determined at Baseline, with the above outcomes analyzed for each sub-group.
Measured: Week 8
Safety and Tolerability Characteristics
Safety and tolerability characteristics in this patient population via clinical laboratory data and adverse events
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roger Goldberg, M.D., MBA
- Sponsor type
- University, hospital or other
- Collaborators
- Ophthalmic Consultants of Boston
- Responsible party
- Sponsor-investigator, Roger Goldberg, M.D., MBA, Bay Area Retina Associates
- Investigators
- Roger A Goldberg, M.D., MBA, Principal investigator, Bay Area Retina AssociatesJeffrey S Heier, M.D., Principal investigator, Ophthalmic Consultants of Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354170
- Sponsor's protocol ID
- STOMP-CSC
- Acronym
- STOMP-CSC
- Status last verified
- Jul 2017
- First submitted
- 29 Jan 2015
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhao M, Celerier I, Bousquet E, Jeanny JC, Jonet L, Savoldelli M, Offret O, Curan A, Farman N, Jaisser F, Behar-Cohen F. Mineralocorticoid receptor is involved in rat and human ocular chorioretinopathy. J Clin Invest. 2012 Jul;122(7):2672-9. doi: 10.1172/JCI61427. Epub 2012 Jun 11.
PubMed 22684104Gemenetzi M, De Salvo G, Lotery AJ. Central serous chorioretinopathy: an update on pathogenesis and treatment. Eye (Lond). 2010 Dec;24(12):1743-56. doi: 10.1038/eye.2010.130. Epub 2010 Oct 8.
PubMed 20930852Bouzas EA, Karadimas P, Pournaras CJ. Central serous chorioretinopathy and glucocorticoids. Surv Ophthalmol. 2002 Sep-Oct;47(5):431-48. doi: 10.1016/s0039-6257(02)00338-7.
PubMed 12431693Tittl MK, Spaide RF, Wong D, Pilotto E, Yannuzzi LA, Fisher YL, Freund B, Guyer DR, Slakter JS, Sorenson JA. Systemic findings associated with central serous chorioretinopathy. Am J Ophthalmol. 1999 Jul;128(1):63-8. doi: 10.1016/s0002-9394(99)00075-6.
PubMed 10482095Yannuzzi LA. Type-A behavior and central serous chorioretinopathy. Retina. 1987 Summer;7(2):111-31. doi: 10.1097/00006982-198700720-00009.
PubMed 3306853Spaide RF, Campeas L, Haas A, Yannuzzi LA, Fisher YL, Guyer DR, Slakter JS, Sorenson JA, Orlock DA. Central serous chorioretinopathy in younger and older adults. Ophthalmology. 1996 Dec;103(12):2070-9; discussion 2079-80. doi: 10.1016/s0161-6420(96)30386-2.
PubMed 9003341Ross A, Ross AH, Mohamed Q. Review and update of central serous chorioretinopathy. Curr Opin Ophthalmol. 2011 May;22(3):166-73. doi: 10.1097/ICU.0b013e3283459826.
PubMed 21427570Castro-Correia J, Coutinho MF, Rosas V, Maia J. Long-term follow-up of central serous retinopathy in 150 patients. Doc Ophthalmol. 1992;81(4):379-86. doi: 10.1007/BF00169099.
PubMed 1486812Gilbert CM, Owens SL, Smith PD, Fine SL. Long-term follow-up of central serous chorioretinopathy. Br J Ophthalmol. 1984 Nov;68(11):815-20. doi: 10.1136/bjo.68.11.815.
PubMed 6541945Bujarborua D. Long-term follow-up of idiopathic central serous chorioretinopathy without laser. Acta Ophthalmol Scand. 2001 Aug;79(4):417-21. doi: 10.1034/j.1600-0420.2001.079004417.x.
PubMed 11453866Folk JC, Thompson HS, Han DP, Brown CK. Visual function abnormalities in central serous retinopathy. Arch Ophthalmol. 1984 Sep;102(9):1299-302. doi: 10.1001/archopht.1984.01040031049021.
PubMed 6477246Chan WM, Lai TY, Lai RY, Liu DT, Lam DS. Half-dose verteporfin photodynamic therapy for acute central serous chorioretinopathy: one-year results of a randomized controlled trial. Ophthalmology. 2008 Oct;115(10):1756-65. doi: 10.1016/j.ophtha.2008.04.014. Epub 2008 Jun 5.
PubMed 18538401Spitznas M, Huke J. Number, shape, and topography of leakage points in acute type I central serous retinopathy. Graefes Arch Clin Exp Ophthalmol. 1987;225(6):437-40. doi: 10.1007/BF02334172.
PubMed 3678855Fujimoto H, Gomi F, Wakabayashi T, Sawa M, Tsujikawa M, Tano Y. Morphologic changes in acute central serous chorioretinopathy evaluated by fourier-domain optical coherence tomography. Ophthalmology. 2008 Sep;115(9):1494-500, 1500.e1-2. doi: 10.1016/j.ophtha.2008.01.021. Epub 2008 Apr 18.
PubMed 18394706Montero JA, Ruiz-Moreno JM. Optical coherence tomography characterisation of idiopathic central serous chorioretinopathy. Br J Ophthalmol. 2005 May;89(5):562-4. doi: 10.1136/bjo.2004.049403.
PubMed 15834085
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Oral Mifepristone for Central Serous Chorioretinopathy. A Placebo-controlled Dose Ranging Study of Mifepristone in the Treatment of CSC (STOMP-CSC)
- ClinicalTrials.gov ID
- NCT02354170
- Acronym / sponsor ID
- STOMP-CSC / STOMP-CSC
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Central Serous Chorioretinopathy, CSC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Roger Goldberg, M.D., MBAUniversity, hospital or other
- Collaborators
- Ophthalmic Consultants of Boston
- Study start
- Jan 2015
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 3 Feb 2015 (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.
The goal of the study is to assess the efficacy and safety of mifepristone 300 or 900-mg once-daily dosing by mouth for 4 weeks in patients with central serous chorioretinopathy.
Detailed description
- Prospective, randomized, double-masked, placebo-controlled dose-ranging study
- Eligible patients will be those with CSC, with symptoms of blurred or distorted vision, with the presence of sub-retinal fluid as documented on optical coherence tomography (OCT) in the central foveal sub-field
- Only one eye of a participant will be included in the study, although both eyes will be evaluated. In patients with bilateral CSC, the eye with more sub-foveal fluid on OCT will be the study eye.
- Patients will be evaluated and treated at one of two study centers:
Ophthalmic Consultants of Boston (OCB), 50 Staniford St., Suite 600, Boston, MA
Bay Area Retina Associates (BARA), 122 La Casa Via, Suite 223, Walnut Creek, CA
- All participants will receive a standard ophthalmic examination as well as fluorescein and indocyanine green angiography and macular OCT per protocol.
- 30 patients will be enrolled, as follows: 10 patients will be randomly assigned to Cohort 1, and will take one (1) mifepristone 300-mg tablet (300 mg total dose) once daily by mouth for 4 weeks. 10 patients will be randomly assigned to Cohort 2, and will take three (3) mifepristone 300-mg tablet (900 mg total dose) once daily by mouth for 4 weeks. 10 patients will be randomly assigned to Cohort 3, and will take placebo tablet(s) once daily by mouth for 4 weeks.
- After completing the enrollment criteria, a subject will be randomized 1:1:1 to Cohort 1, 2, or 3.
- During the Baseline visit and at the Week 2, 4, and 8 visits, all subjects will have laboratory testing of the following lab tests: serum electrolytes, BUN and creatinine, liver function tests
- Prior to initiating dosing of the study drug, all women of child-bearing potential (WOCBP) will have a serum beta-HCG assessed to rule out pregnancy; all WOCBP who are enrolled in the study will be required to use barrier contraception throughout the study.
- Adverse events will be tracked at each visit (see "Data Safety and Monitoring Plan" below)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (m300) | Experimental | Drug: MifepristoneOne (1) 300-mg mifepristone tablet, taken once daily for 4 weeks |
| Cohort 2 (m900) | Experimental | Drug: MifepristoneThree (3) 300-mg mifepristone tablets (900-mg dose), taken once daily for 4 weeks |
| Cohort 3 (Placebo) | Placebo comparator | Drug: PlaceboPlacebo taken once daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of central serous chorioretinopathy (CSC) with symptoms 6 weeks or prior documented episodes of sub-retinal fluid; patients who have had previous treatment for CSC may be included
- Presence of sub-retinal fluid as documented on optical coherence tomography (OCT) in the central foveal sub-field
- Age 18 or over
- Willing and able to comply with clinic visits and study-related procedures
- Ability to give written informed consent
Key exclusion criteria (13 listed)
- Age less than 18
- Persons with impaired decision-making ability.
- Women who are known to be breast-feeding, pregnant or are actively trying to conceive.
- Additional eye disease affecting the macula, posterior retina, or ocular media that would limit or prevent the acquisition of OCT and angiographic images.
- At screening, serum potassium < LLN, BUN > 1.5 ULN, serum creatinine >1.5 ULN, AST > 1.5 ULN, ALT >1.5 ULN, bilirubin > 1.5 ULN, alkaline phosphatase > 1.5 ULN, serum albumin >1.5 ULN or <LLN.
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 |
|---|---|---|
| Mifepristone | Drug | Cohort 1 (m300), Cohort 2 (m900) |
| Placebo | Drug | Cohort 3 (Placebo) |
Primary outcome
Resolution of Sub-retinal Fluid
Time frame: 4 weeks after treatment
Presence or absence of subretinal fluid on spectral-domain OCT after 4 weeks of treatment with mifepristone 300 or 900 mg daily, compared with placebo.
9 secondary outcomes
Change in sub-retinal fluid and/or intraretinal fluid
Time frame: Week 1, 2, 4, and 8
Best Corrected Visual Acuity
Time frame: Week 1, 2, 4, and 8
Change in macular thickness
Time frame: Week 1, 2, 4, and 8
Change in foveal thickness
Time frame: Week 1, 2, 4, and 8
Change in choroidal thickness
Time frame: Week 1, 2, 4, and 8
Dye leakage in vasculature
Time frame: Week 4 and 8
Change in OCT characteristics in the fellow eye
Time frame: Week 8
Proportion of acute vs. chronic CSC patients
Time frame: Week 8
Safety and Tolerability Characteristics
Time frame: Week 8
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 26 Jul 2017.
- Background: PubMed 22684104Zhao M, Celerier I, Bousquet E, Jeanny JC, Jonet L, Savoldelli M, Offret O, Curan A, Farman N, Jaisser F, Behar-Cohen F. Mineralocorticoid receptor is involved in rat and human ocular chorioretinopathy. J Clin Invest. 2012 Jul;122(7):2672-9. doi: 10.1172/JCI61427. Epub 2012 Jun 11.
- Background: PubMed 20930852Gemenetzi M, De Salvo G, Lotery AJ. Central serous chorioretinopathy: an update on pathogenesis and treatment. Eye (Lond). 2010 Dec;24(12):1743-56. doi: 10.1038/eye.2010.130. Epub 2010 Oct 8.
- Background: PubMed 12431693Bouzas EA, Karadimas P, Pournaras CJ. Central serous chorioretinopathy and glucocorticoids. Surv Ophthalmol. 2002 Sep-Oct;47(5):431-48. doi: 10.1016/s0039-6257(02)00338-7.
- Background: PubMed 10482095Tittl MK, Spaide RF, Wong D, Pilotto E, Yannuzzi LA, Fisher YL, Freund B, Guyer DR, Slakter JS, Sorenson JA. Systemic findings associated with central serous chorioretinopathy. Am J Ophthalmol. 1999 Jul;128(1):63-8. doi: 10.1016/s0002-9394(99)00075-6.
- Background: PubMed 3306853Yannuzzi LA. Type-A behavior and central serous chorioretinopathy. Retina. 1987 Summer;7(2):111-31. doi: 10.1097/00006982-198700720-00009.
- Background: PubMed 9003341Spaide RF, Campeas L, Haas A, Yannuzzi LA, Fisher YL, Guyer DR, Slakter JS, Sorenson JA, Orlock DA. Central serous chorioretinopathy in younger and older adults. Ophthalmology. 1996 Dec;103(12):2070-9; discussion 2079-80. doi: 10.1016/s0161-6420(96)30386-2.
- Background: PubMed 21427570Ross A, Ross AH, Mohamed Q. Review and update of central serous chorioretinopathy. Curr Opin Ophthalmol. 2011 May;22(3):166-73. doi: 10.1097/ICU.0b013e3283459826.
- Background: PubMed 1486812Castro-Correia J, Coutinho MF, Rosas V, Maia J. Long-term follow-up of central serous retinopathy in 150 patients. Doc Ophthalmol. 1992;81(4):379-86. doi: 10.1007/BF00169099.
- Background: PubMed 6541945Gilbert CM, Owens SL, Smith PD, Fine SL. Long-term follow-up of central serous chorioretinopathy. Br J Ophthalmol. 1984 Nov;68(11):815-20. doi: 10.1136/bjo.68.11.815.
- Background: PubMed 11453866Bujarborua D. Long-term follow-up of idiopathic central serous chorioretinopathy without laser. Acta Ophthalmol Scand. 2001 Aug;79(4):417-21. doi: 10.1034/j.1600-0420.2001.079004417.x.
- Background: PubMed 6477246Folk JC, Thompson HS, Han DP, Brown CK. Visual function abnormalities in central serous retinopathy. Arch Ophthalmol. 1984 Sep;102(9):1299-302. doi: 10.1001/archopht.1984.01040031049021.
- Background: PubMed 18538401Chan WM, Lai TY, Lai RY, Liu DT, Lam DS. Half-dose verteporfin photodynamic therapy for acute central serous chorioretinopathy: one-year results of a randomized controlled trial. Ophthalmology. 2008 Oct;115(10):1756-65. doi: 10.1016/j.ophtha.2008.04.014. Epub 2008 Jun 5.
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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.
Roger A Goldberg, M.D., MBA principal investigator
Bay Area Retina Associates
Jeffrey S Heier, M.D. principal investigator
Ophthalmic Consultants of Boston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone in people with Central Serous Chorioretinopathy, run by Roger Goldberg, M.D., MBA at 2 sites 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 13 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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Resolution of Sub-retinal Fluid (time frame: 4 weeks after treatment). 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 NCT02354170, which also lists 36 linked publications.
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 26 Jul 2017.