Formulated PSTA Injection Versus PATA Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions

Study Overview
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Brief Summary
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The aim of this study is to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone in the management of macular edema secondary to non-ischemic retinal vein occlusions, either central or branch.

Official Title
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Formulated Posterior Subtenon Triamcinolone (PSTA) Injection Versus Posterior Subtenon Triamcinolone Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions

Conditions
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Macula Edema

Intervention / Treatment
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* Drug: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate
* Drug: Triamcinolone Acetonide alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diminution vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch, as evidenced by clinical and angiographic evaluation CMT ≥ 250 µ. Willing to participate in the study Exclusion Criteria: Unwilling to participate in the study. Ischemic RVO Prior laser treatment Glaucoma/Ocular Hypertension Cataract which lead to difficulty in the evaluation of macula Vitreous hemorrhage Macular ischemia Iris neovascularisation patients with intravitreal injection of anti VEGFs, steroid, or any intraocular surgery 3 months prior to the inclusion.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Non-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: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate<br>* formulated with sodium hyaluronate and chondroitin sulfate<br>|
| Active Comparator: Posterior Sub Tenon Triamcinolone alone<br> | Drug: Triamcinolone Acetonide alone<br>* Triamcinolone Acetonide alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity (BCVA) | will be measured with the Snellen chart | Baseline | 
| Best-corrected visual acuity (BCVA) | will be measured with the Snellen chart | at 1st month | 
| Best-corrected visual acuity (BCVA) | will be measured with the Snellen chart | at 3rd month | 
| Best-corrected visual acuity (BCVA) | will be measured with the Snellen chart | at 6th month | 
| central macular thickness ( CMT) | CMT will be measured with OCT | at baseline | 
| central macular thickness ( CMT) | CMT will be measured with OCT | at 1st month | 
| central macular thickness ( CMT) | CMT will be measured with OCT | at 3rd month | 
| central macular thickness ( CMT) | CMT will be measured with OCT | at 6th month |