NCT05337332

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 14, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

April 13, 2022

Last Update Submit

April 13, 2022

Conditions

Central Serous ChorioretinopathyIrvine-Gass SyndromePars PlanitisCystoid Macular Edema

Keywords

Central serous chorioretinopathyCystoid macular edema

Outcome Measures

Primary Outcomes (1)

  • Central macular thickness

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

    Baseline and 12 months after injection.

Secondary Outcomes (1)

  • Best corrected visual acuity

    Baseline and 12 months after injection.

Other Outcomes (1)

  • Intraocular pressure

    Baseline and 12 months after injection.

Study Arms (2)

Central serous chorioretinopathy group

EXPERIMENTAL

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

Drug: Triamcinolone Acetonide

Irvine-Gass Syndrome group

EXPERIMENTAL

Cases with cystoid macular edema due to irvine-gass syndrome that will be injected with suprachoroidal triamcinolone acetonide

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone AcetonideDRUG

Suprachoroidal injection of triamcinolone acetonide

Also known as: Suprachoroidal triamcinolone acetonide injection (SCTA)
Central serous chorioretinopathy groupIrvine-Gass Syndrome group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy

Banhā, QA, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Central Serous ChorioretinopathyMacular EdemaPars Planitis

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesMacular DegenerationRetinal DegenerationChoroiditisChoroid DiseasesUveal DiseasesUveitis, PosteriorPanuveitisUveitisUveitis, Intermediate

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Ahmed A Abdelshafy, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

01222328766ahmad4lg@gmail.com

Marwa Abdelshafy, MD

CONTACT

01222328766ahmad4lg@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ophthalmology

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 20, 2022

Study Start

April 14, 2022

Primary Completion

May 30, 2023

Study Completion

June 1, 2023

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)