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

Alazher University Dean

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema of Left Eye
• Intervention / Treatment: Drug: Formulated Triamcinolone; Drug: Triamcinolone Acetonide

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • New Damietta
    • Damieta, New Damietta, Egypt, 34517
      • Ehab tharwat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Formulated Posterior Sub Tenon Triamcinolone	Drug: Formulated Triamcinolone; Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate
Active Comparator: Posterior Sub Tenon Triamcinolone alone	Drug: Triamcinolone Acetonide; 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
Active Comparator: suprachoroidal Triamcinolone	Drug: Triamcinolone Acetonide; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 17, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: PSTA and DME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No