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Status unknownNCT05337332Updated Apr 20, 2022

Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases

A Phase 2/3 interventional study of Triamcinolone Acetonide in Central Serous Chorioretinopathy, Irvine-Gass Syndrome and Pars Planitis, sponsored by Benha University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-04-20.

Sponsored by Benha University · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Central Serous Chorioretinopathy
  • Irvine-Gass Syndrome
  • Pars Planitis
  • Cystoid Macular Edema

Keywords

  • Central serous chorioretinopathy
  • Cystoid macular edema
03

In context

Central Serous Chorioretinopathy

84 studies on the registry are indexed under Central Serous Chorioretinopathy; 14 are open to participants now.

This study's planned enrollment of 50 is above the median of 35 across 60 interventional studies indexed under Central Serous Chorioretinopathy.

Browse Central Serous Chorioretinopathy studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Browse Benha University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • other retinal diseases that may affect CMT and final visual outcome.
  • Patients with dense corneal opacity.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Central serous chorioretinopathy group

    Cases with central serous chorioretinopathy (CSR) that will be injected with suprachoroidal triamcinolone acetonide.

    Drug: Triamcinolone Acetonide

  • 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

Interventions

  • DrugTriamcinolone Acetonide

    Suprachoroidal injection of triamcinolone acetonide

    Also known as: Suprachoroidal triamcinolone acetonide injection (SCTA)

06

What researchers measure

Primary outcomes

  1. Central macular thickness

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

    Time frame: Baseline and 12 months after injection.

Secondary outcomes

  1. Best corrected visual acuity

    Changes in best corrected visual acuity (BCVA) measured in logarithm of minimal angle of resolution (LogMAR) by chart projector.

    Time frame: Baseline and 12 months after injection.

Other outcomes

  1. Intraocular pressure

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

    Time frame: Baseline and 12 months after injection.

07

Study locations

1 of 1 sites recruiting
  • Ahmed Abdelshafy
    Banhā, QA 13511, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2022 (actual). Primary completion is estimated for May 2023, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2022
First posted
Apr 20, 2022
StartActual
Apr 14, 2022
Primary completionEst.
May 30, 2023
CompletionEst.
Jun 1, 2023
Last update
Apr 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05337332
Lead sponsor
Benha University
Responsible party
Ahmed Abdelshafy (Assistant professor of Ophthalmology, Benha University) — Principal investigator
First posted
Apr 20, 2022
Start date
Apr 14, 2022
Primary completion
May 30, 2023 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Apr 20, 2022

Study contacts

Ahmed Abdelshafy, MD
Contact
ahmad4lg@gmail.com
01222328766
Marwa Abdelshafy, MD
Contact
ahmad4lg@gmail.com
01222328766
Ahmed A Abdelshafy, MD
principal investigator · Benha University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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