Back to resultsSuprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.
Primary Purpose
Diabetic Macular Edema of Left Eye
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Formulated Triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema of Left Eye
Eligibility Criteria
Inclusion Criteria:
- Diminution of vision due to diabetic macular edema.
- CMT ≥ 250 µ.
- Willing to participate in the study.
Exclusion Criteria:
- Unwilling to participate in the study, 2)
- Ischemic RVO,
- previous laser treatment
- Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris,
- patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion,
- 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.
Sites / Locations
- Ehab tharwat
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Formulated Posterior Sub Tenon Triamcinolone
Posterior Sub Tenon Triamcinolone alone
suprachoroidal Triamcinolone
Arm Description
Outcomes
Primary Outcome Measures
BCVA
Best-corrected visual acuity
BCVA
Best-corrected visual acuity
BCVA
Best-corrected visual acuity
BCVA
Best-corrected visual acuity
CMT
CENTRAL MACULAR THICKNESS
CMT
CENTRAL MACULAR THICKNESS
CMT
CENTRAL MACULAR THICKNESS
CMT
CENTRAL MACULAR THICKNESS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05464953
Brief Title
Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.
Official Title
Alazher University Dean
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema of Left Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Formulated Posterior Sub Tenon Triamcinolone
Arm Type
Active Comparator
Arm Title
Posterior Sub Tenon Triamcinolone alone
Arm Type
Active Comparator
Arm Title
suprachoroidal Triamcinolone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Formulated Triamcinolone
Intervention Description
Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate
Primary Outcome Measure Information:
Title
BCVA
Description
Best-corrected visual acuity
Time Frame
Base line
Title
BCVA
Description
Best-corrected visual acuity
Time Frame
at 1st month
Title
BCVA
Description
Best-corrected visual acuity
Time Frame
at 3rd month
Title
BCVA
Description
Best-corrected visual acuity
Time Frame
at 6th month
Title
CMT
Description
CENTRAL MACULAR THICKNESS
Time Frame
at baseline
Title
CMT
Description
CENTRAL MACULAR THICKNESS
Time Frame
at 1st month
Title
CMT
Description
CENTRAL MACULAR THICKNESS
Time Frame
at 3rd month
Title
CMT
Description
CENTRAL MACULAR THICKNESS
Time Frame
at 6th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diminution of vision due to diabetic macular edema.
CMT ≥ 250 µ.
Willing to participate in the study.
Exclusion Criteria:
Unwilling to participate in the study, 2)
Ischemic RVO,
previous laser treatment
Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris,
patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion,
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.
Facility Information:
Facility Name
Ehab tharwat
City
Damieta
State/Province
New Damietta
ZIP/Postal Code
34517
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.
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