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

• Sponsor: Dar El Oyoun Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05847049
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Central Serous Chorioretinopathy	Other: Eplerenone , Intravitreal Aflibercept and Topical nepafenac therapy

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

• Study Type: Observational
• Actual Enrollment: 16 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Influence of Combined Eplerenone , Intravitreal Aflibercept and Topical Nepafenac Therapy on Serous Foveal Detachment in Central Serous Chorioretinopathy (CSCR)
• Actual Study Start Date: Feb 28, 2023
• Actual Primary Completion Date: Mar 25, 2023
• Actual Study Completion Date: Apr 6, 2023

Outcome Measures

Primary Outcome Measures

1. Change in central macular thickness (CMT ) in microns [(baseline, 6 months)]

   reduction in CMT after therapy

2. Change in serous detachment height (SDH) in microns [(baseline, 6 months)]

   reduction in SDH after therapy

Secondary Outcome Measures

1. Change in BCVA [(baseline, 6 months)]

   number of lines of improvement in BCVA after therapy

2. Duration of Follow-up ( in months) [(baseline, 6 months)]

   Duration of Follow-up ( in months)

3. Complications (Eplerenone, Aflibercept, and nepafenac) [(baseline, 6 months)]

   present or absent

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr alainy faculty of medicine	Cairo		Egypt	12311

Sponsors and Collaborators

• Dar El Oyoun Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wael Ahmed Ewais, Associate professor of ophthalmology, Dar El Oyoun Hospital
• ClinicalTrials.gov Identifier: NCT05847049
• Other Study ID Numbers: N-20-2023
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Central Serous Chorioretinopathy; Nepafenac; Aflibercept; Eplerenone

Study Results

No Results Posted as of May 6, 2023