Central Serous ChorioretinopathyCSCRNCT05847049
Eplerenone, Aflibercept and Topical Nepafenac Serous Foveal Deta Chment in Central Serous Chorioretinopathy
An observational study of Central Serous Chorioretinopathy, run by Dar El Oyoun Hospital at 1 site in Egypt.
Trial summary
describing the influence of; combined Eplerenone, intravitreal Aflibercept, and topical Nepafenac; on serous foveal detachment in eyes with CSCR Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2023to 6 Apr 2023
- Phase
- Observational
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period between 2015 and 2021
Who may be able to join
- CSCR eyes treated by combination of Eplerenone, Aflibercept and Nepafenac.
Who cannot join
- • CSCR treated by other modalities
- CSCR treated by just 1 or 2 components of :Eplerenone, Aflibercept and Nepafenac
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Combined Eplerenone , Intravitreal Aflibercept and Topical Nepafenac Therapy on Serous Foveal Detachment in Central Serous Chorioretinopathy (CSCR)
describing the influence of; combined Eplerenone, intravitreal Aflibercept, and topical Nepafenac; on serous foveal detachment in eyes with CSCR
Read the detailed description
Retrospective Review of records of eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period between 2015 and 2021
After checking inclusion and exclusion criteria; we will enroll all cases that have been treated by the combination of eplerenone, intravitreal aflibercept and topical nepafenac.
Investigators collected and recorded the following data:
- Age
- Gender
- Systemic hypertension (present or not)
- Smoking (Yes / No)
- Best corrected visual acuity (BCVA) (baseline, final)
- Central macular thickness (CMT) (baseline, final)
- Serous detachment Height (SDH) (baseline, final)
- Duration of Follow-up ( in months)
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy
- 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.
Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapyOther
Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central macular thickness (CMT ) in microns
reduction in CMT after therapy
Measured: (baseline, 6 months)
Change in serous detachment height (SDH) in microns
reduction in SDH after therapy
Measured: (baseline, 6 months)
Secondary outcomes (3)
Change in BCVA
number of lines of improvement in BCVA after therapy
Measured: (baseline, 6 months)
Duration of Follow-up ( in months)
Duration of Follow-up ( in months)
Measured: (baseline, 6 months)
Complications (Eplerenone, Aflibercept, and nepafenac)
present or absent
Measured: (baseline, 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start28 Feb 2023
- Primary completion25 Mar 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar El Oyoun Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Ahmed Ewais, Dar El Oyoun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847049
- Sponsor's protocol ID
- N-20-2023
- Acronym
- CSCR
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Combined Eplerenone , Intravitreal Aflibercept and Topical Nepafenac Therapy on Serous Foveal Detachment in Central Serous Chorioretinopathy (CSCR)
- ClinicalTrials.gov ID
- NCT05847049
- Acronym / sponsor ID
- CSCR / N-20-2023
- Conditions
- Central Serous Chorioretinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dar El Oyoun HospitalUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 6 May 2023 (actual)
- 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.
describing the influence of; combined Eplerenone, intravitreal Aflibercept, and topical Nepafenac; on serous foveal detachment in eyes with CSCR
Detailed description
Retrospective Review of records of eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period between 2015 and 2021
After checking inclusion and exclusion criteria; we will enroll all cases that have been treated by the combination of eplerenone, intravitreal aflibercept and topical nepafenac.
Investigators collected and recorded the following data:
- Age
- Gender
- Systemic hypertension (present or not)
- Smoking (Yes / No)
- Best corrected visual acuity (BCVA) (baseline, final)
- Central macular thickness (CMT) (baseline, final)
- Serous detachment Height (SDH) (baseline, final)
- Duration of Follow-up ( in months)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period between 2015 and 2021
Key inclusion criteria (1 listed)
- CSCR eyes treated by combination of Eplerenone, Aflibercept and Nepafenac.
Key exclusion criteria (2 listed)
- • CSCR treated by other modalities
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 |
|---|---|---|
| Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapyEplerenone , Intravitreal Aflibercept and Topical nepafenac therapy | Other | – |
Primary outcome
Change in central macular thickness (CMT ) in microns
Time frame: (baseline, 6 months)
reduction in CMT after therapy
Change in serous detachment height (SDH) in microns
Time frame: (baseline, 6 months)
reduction in SDH after therapy
3 secondary outcomes
Change in BCVA
Time frame: (baseline, 6 months)
Duration of Follow-up ( in months)
Time frame: (baseline, 6 months)
Complications (Eplerenone, Aflibercept, and nepafenac)
Time frame: (baseline, 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 6 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Serous Chorioretinopathy, run by Dar El Oyoun Hospital at 1 site in Egypt.
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 2 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 May 2023. 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 Egypt. 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?
Change in central macular thickness (CMT ) in microns (time frame: (baseline, 6 months)). 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 6 May 2023.