Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.

Study Overview
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Brief Summary
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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.

Official Title
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Alazher University Dean

Conditions
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Diabetic Macular Edema of Left Eye

Intervention / Treatment
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* Drug: Triamcinolone Acetonide
* Drug: Formulated Triamcinolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formulated Posterior Sub Tenon Triamcinolone<br> | Drug: Formulated Triamcinolone<br>* Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate<br>|
| Active Comparator: Posterior Sub Tenon Triamcinolone alone<br> | Drug: Triamcinolone Acetonide<br>* 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<br>|
| Active Comparator: suprachoroidal Triamcinolone<br> | Drug: Triamcinolone Acetonide<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |