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

Not Applicable

Completed

• Conditions: Diabetic Macular Edema of Left Eye
• Interventions: Drug: Formulated Triamcinolone; Drug: Triamcinolone Acetonide

• Registration Number: NCT05464953
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Primary Completion: 2022-04-20
• Study Completion: 2022-04-30
• Status Verified: 2022-07
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-17
• Last Update Submitted: 2022-07-17
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Diminution of vision due to diabetic macular edema.
• CMT ≥ 250 µ.
• Willing to participate in the study.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formulated Posterior Sub Tenon Triamcinolone	Formulated Triamcinolone	-
Posterior Sub Tenon Triamcinolone alone	Triamcinolone Acetonide	-
suprachoroidal Triamcinolone	Triamcinolone Acetonide	-

Primary Outcome Measures

Name	Time	Method
BCVA	at 6th month	Best-corrected visual acuity
CMT	at 6th month	CENTRAL MACULAR THICKNESS

Trial Locations

Locations (1)

Ehab tharwat; 🇪🇬 Damieta, New Damietta, Egypt