Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)

August 9, 2022 updated by: Ahmed Abdelshafy, Benha University

One Year Results for Suprachoroidal Triamcinolone Acetonide Injection in Various Retinal Diseases

Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, we aim to analyze the long term results of suprachoroidal injection in treating various retinal diseases to focus on its efficacy, safety and long term ocular effects as ocular hypertension, cataract progression and macular edema resolution.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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 Locations

  • Egypt
    • Benha
      • Banhā, Benha, Egypt, 13511
        • Recruiting
        • Ahmed Abdelshafy Tabl
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmed A Tabl, MD

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:
  • Diabetic macular edema
  • Vogt-koyanagi Harada disease
  • Retinal vein occlusion.

Exclusion Criteria:

  • other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
  • Cases with confirmed diagnosis of glaucoma.

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
Active Comparator: Diabetic macular edema
Cases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography.
Drug: Suprachoroidal triamcinolone acetonide injection
Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.
Active Comparator: Vogt-koyanagi harada
Cases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography.
Drug: Suprachoroidal triamcinolone acetonide injection
Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.
Active Comparator: Retinal vein occlusion
Cases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography.
Drug: Suprachoroidal triamcinolone acetonide injection
Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: Baseline and up to one year after injection.
Changes noted in vision after injection measured 8n logMar units by snellen chart.
Baseline and up to one year after injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central macular thickness
Time Frame: Baseline and up to one year after injection.
Changes noted in central macular thickness after injection measured by optical coherence tomography in microns.
Baseline and up to one year after injection.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: Baseline and up to one year after injection.
Changes noted in intraocular pressure after injection measured by applanation tonometry in millimeter mercury.
Baseline and up to one year 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 Tabl, 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)

July 10, 2022

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

August 15, 2023

Study Registration Dates

First Submitted

August 9, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc-11-22

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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