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OpenTrials
Completed

NCT Number: NCT05464953

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

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.

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Key information

Conditions

Diabetic Macular Edema of Left Eye

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcinolone Acetonide

Drug

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

Formulated Triamcinolone

Drug

Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate

Primary outcomes

  1. BCVA

    Time frame: Base line

    Best-corrected visual acuity

  2. BCVA

    Time frame: at 1st month

    Best-corrected visual acuity

  3. BCVA

    Time frame: at 3rd month

    Best-corrected visual acuity

  4. BCVA

    Time frame: at 6th month

    Best-corrected visual acuity

  5. CMT

    Time frame: at baseline

    CENTRAL MACULAR THICKNESS

  6. CMT

    Time frame: at 1st month

    CENTRAL MACULAR THICKNESS

  7. CMT

    Time frame: at 3rd month

    CENTRAL MACULAR THICKNESS

  8. CMT

    Time frame: at 6th month

    CENTRAL MACULAR THICKNESS

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Alazher University Dean

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.