Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.
Alazher University Dean
1 other identifier
interventional
75
1 country
1
Brief Summary
Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision impairment and blindness worldwide. Diabetic retinopathy (DR) is the most common retinal vascular disorder and is the leading cause of vision loss among patients aged 25 to 74 years. Aim to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone versus suprachoroidal triamcinolone in the management of diabetic macular edema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
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
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFirst Submitted
Initial submission to the registry
July 17, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedJuly 19, 2022
July 1, 2022
2.2 years
July 17, 2022
July 17, 2022
Conditions
Outcome Measures
Primary Outcomes (8)
BCVA
Best-corrected visual acuity
Base line
BCVA
Best-corrected visual acuity
at 1st month
BCVA
Best-corrected visual acuity
at 3rd month
BCVA
Best-corrected visual acuity
at 6th month
CMT
CENTRAL MACULAR THICKNESS
at baseline
CMT
CENTRAL MACULAR THICKNESS
at 1st month
CMT
CENTRAL MACULAR THICKNESS
at 3rd month
CMT
CENTRAL MACULAR THICKNESS
at 6th month
Study Arms (3)
Formulated Posterior Sub Tenon Triamcinolone
ACTIVE COMPARATORPosterior Sub Tenon Triamcinolone alone
ACTIVE COMPARATORsuprachoroidal Triamcinolone
ACTIVE COMPARATORInterventions
Triamcinolone Acetonide is a corticosteroid that has antiangiogenic and anti-inflammatory effects that can inhibit the expression of VEGF and other proinflammatory cytokines, improving best-corrected visual acuity and decreasing central retinal thickness (CRT) in patients with macular edema
Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate
Eligibility Criteria
You may qualify if:
- Diminution of vision due to diabetic macular edema.
- CMT ≥ 250 µ.
- Willing to participate in the study.
You may not qualify if:
- Unwilling to participate in the study, 2)
- Ischemic RVO,
- previous laser treatment
- Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris,
- Cardiac co-morbidities result in significant hemodynamic changes, 7)Respiratory diseases need treatment with antibiotics,
- Suffering from other chronic diseases as diabetes,
- Patient with allergy from triamcinolone acetonide.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ehab tharwat
Damietta, New Damietta, 34517, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
- Dr
Study Record Dates
First Submitted
July 17, 2022
First Posted
July 19, 2022
Study Start
January 20, 2020
Primary Completion
April 20, 2022
Study Completion
April 30, 2022
Last Updated
July 19, 2022
Record last verified: 2022-07