Eplerenone, Aflibercept and Topical Nepafenac Serous Foveal Deta Chment in Central Serous Chorioretinopathy (CSCR)

May 5, 2023 updated by: Wael Ahmed Ewais, Dar El Oyoun Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12311
        • Kasr Alainy Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BCVA
Time Frame: (baseline, 6 months)
number of lines of improvement in BCVA after therapy
(baseline, 6 months)
Duration of Follow-up ( in months)
Time Frame: (baseline, 6 months)
Duration of Follow-up ( in months)
(baseline, 6 months)
Complications (Eplerenone, Aflibercept, and nepafenac)
Time Frame: (baseline, 6 months)
present or absent
(baseline, 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dar El Oyoun Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Actual)

March 25, 2023

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Estimate)

May 8, 2023

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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