Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases

April 13, 2022 updated by: Ahmed Abdelshafy, Benha University

Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results

Suprachoroidal injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Suprachoroidal triamcinolone acetonide injection is used to treat various retinal diseases, higher concentration of the injected material is found when the suprachoroidal space is used as an intraocular delivery pathway when compared to the conventional intravitreal pathway.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • QA
      • Banhā, QA, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy
        • Contact:

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery.

Exclusion Criteria:

  • other retinal diseases that may affect CMT and final visual outcome.
  • Patients with dense corneal opacity.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Central serous chorioretinopathy group
Cases with central serous chorioretinopathy (CSR) that will be injected with suprachoroidal triamcinolone acetonide.
Drug: Triamcinolone Acetonide
Suprachoroidal injection of triamcinolone acetonide
Other Names:
  • Suprachoroidal triamcinolone acetonide injection (SCTA)
Experimental: Irvine-Gass Syndrome group
Cases with cystoid macular edema due to irvine-gass syndrome that will be injected with suprachoroidal triamcinolone acetonide
Drug: Triamcinolone Acetonide
Suprachoroidal injection of triamcinolone acetonide
Other Names:
  • Suprachoroidal triamcinolone acetonide injection (SCTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central macular thickness
Time Frame: Baseline and 12 months after injection.
Changes in central macular thickness (CMT) measured in millimeters (mm) by optical coherence tomography (OCT)
Baseline and 12 months after injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity
Time Frame: Baseline and 12 months after injection.
Changes in best corrected visual acuity (BCVA) measured in logarithm of minimal angle of resolution (LogMAR) by chart projector.
Baseline and 12 months after injection.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: Baseline and 12 months after injection.
Changes in intraocular pressure (IOP) measured in millimeter mercury (mmHg) by applanation tonometry.
Baseline and 12 months after injection.

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Ahmed A Abdelshafy, MD, Benha University

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)

April 14, 2022

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

April 13, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 7-7-22

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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