NCT05847049

Brief Summary

describing the influence of; combined Eplerenone, intravitreal Aflibercept, and topical Nepafenac; on serous foveal detachment in eyes with CSCR

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

25 days

First QC Date

April 5, 2023

Last Update Submit

May 5, 2023

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • Change in BCVA

    (baseline, 6 months)

  • Duration of Follow-up ( in months)

    (baseline, 6 months)

  • Complications (Eplerenone, Aflibercept, and nepafenac)

    (baseline, 6 months)

Interventions

Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapyOTHER

Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy faculty of medicine

Cairo, 12311, Egypt

Location

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of ophthalmology

Study Record Dates

First Submitted

April 5, 2023

First Posted

May 6, 2023

Study Start

February 28, 2023

Primary Completion

March 25, 2023

Study Completion

April 6, 2023

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)