Clincosm LogoSign in Get a demo

Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05337332
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
13.6
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Triamcinolone Acetonide
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results
Actual Study Start Date :
Apr 14, 2022
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Central macular thickness [Baseline and 12 months after injection.]

      Changes in central macular thickness (CMT) measured in millimeters (mm) by optical coherence tomography (OCT)

    Secondary Outcome Measures

    1. Best corrected visual acuity [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.

    Other Outcome Measures

    1. Intraocular pressure [Baseline and 12 months after injection.]

      Changes in intraocular pressure (IOP) measured in millimeter mercury (mmHg) by applanation tonometry.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed Abdelshafy Banhā QA Egypt 13511

    Sponsors and Collaborators

    • Benha University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Abdelshafy, Assistant professor of Ophthalmology, Benha University
    ClinicalTrials.gov Identifier:
    NCT05337332
    Other Study ID Numbers:
    • RC 7-7-22
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    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
    Keywords provided by Ahmed Abdelshafy, Assistant professor of Ophthalmology, Benha University
    Central serous chorioretinopathy
    Cystoid macular edema
    Additional relevant MeSH terms:
    Macular Edema
    Central Serous Chorioretinopathy
    Pars Planitis
    Triamcinolone
    Triamcinolone Acetonide
    Triamcinolone hexacetonide
    Triamcinolone diacetate

    Study Results

    No Results Posted as of Apr 20, 2022