NCT05288192

Brief Summary

Changes after suprachoroidal injection are analyzed for statistical analysis.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 15, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

March 11, 2022

Last Update Submit

March 11, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in visual acuity

    Changes in best corrected visual acuity after injection

    Monthly after injection till six months of follow up

  • Changes in central foveal thickness

    Changes in central macular thickness after injection

    Monthly after injection till six months of follow up

Secondary Outcomes (2)

  • Changes in intraocular pressure

    Monthly after injection till six months of follow up

  • Changes in lens

    Monthly after injection till six months of follow up

Study Arms (2)

Suprachoroidal triamcinolone injection

ACTIVE COMPARATOR

Eyes treated with suprachoroidal injection of triamcinolone acetonide.

Drug: Suprachoroidal triamcinolone acetonide (SCTA) injection

Non-treated eyes

NO INTERVENTION

Eyes that are receiving no interventions during the study period.

Interventions

Suprachoroidal injection of 4mg/0.1ml of triamcinolone acetonide.

Also known as: SCTA injection
Suprachoroidal triamcinolone injection

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study.
  • Bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies.

You may not qualify if:

  • Other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations.
  • Choroidal neovascularization that require anti-vascular endothelial growth factors.
  • Patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, QA, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

CataractMacular Edema

Interventions

Injections

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Ahmed A Tabl, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdelshafy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 21, 2022

Study Start

February 15, 2022

Primary Completion

August 30, 2022

Study Completion

September 1, 2022

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations