Eplerenone, Aflibercept and Topical Nepafenac Serous Fove... | NCT05847049

Studies
Eplerenone, Aflibercept and Topical Nepafenac Serous Foveal Deta Chment in Central Serous Chorioretinopathy

NCT05847049

Sponsor

Dar El Oyoun Hospital

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Central Serous Chorioretinopathy

Interventions

Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2023Actual

Primary Completion Date

Mar 25, 2023Actual

Completion Date

Apr 6, 2023Actual

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

May 5, 2023

First Posted Date

May 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2023

Last Update Posted Date

May 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wael Ahmed Ewais, Associate professor of ophthalmology, Dar El Oyoun HospitalPrincipal Investigator

Lead Sponsor

Dar El Oyoun HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy	Other	Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in central macular thickness (CMT ) in microns	reduction in CMT after therapy	(baseline, 6 months)
Change in serous detachment height (SDH) in microns	reduction in SDH after therapy	(baseline, 6 months)

Secondary Outcomes

Measure	Description	Time Frame
Change in BCVA	number of lines of improvement in BCVA after therapy	(baseline, 6 months)
Duration of Follow-up ( in months)	Duration of Follow-up ( in months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CSCR eyes treated by combination of Eplerenone, Aflibercept and Nepafenac.

Exclusion Criteria:

• CSCR treated by other modalities
- CSCR treated by just 1 or 2 components of :Eplerenone, Aflibercept and Nepafenac

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period between 2015 and 2021

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr alainy faculty of medicine		Cairo		12311	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056833	Central Serous Chorioretinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077545	Eplerenone

Ancestor Terms

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256

Browse Leaves

Not provided

Browse Branches

Not provided