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OpenTrials
Completed

NCT Number: NCT05345808

Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions

Retinal vein occlusion (RVO) is considered the second vascular disorder of the retina after diabetic retinopathy. Patients with RVO are at risk of the development of macular edema. Different treatment modalities for macular edema include LASER therapy, antivascular endothelial growth factor (VEGF), and triamcinolone.

Aim To detect the efficacy of formulated Triamcinolone Acetonide(TA) injection in the posterior subtenon space to manage macular edema secondary to non-ischemic RVOs, either central or branch.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akram Fekry Elgazzar

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 macular edema secondary to non-ischemic retinal vein occlusions, either central or branch
  • CMT ≥ 250 µ,
  • Willing to participate in the study.

Exclusion criteria

  • Unwilling to participate in the study
  • 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
  • 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 formulated with chondroitin sulfate and sodium hyaluronate

Primary outcomes

  1. Best corrected visual acuity

    Time frame: at the base line

    Measured by snellen chart

  2. Best corrected visual acuity

    Time frame: at 1st month

    Measured by snellen chart

  3. Best corrected visual acuity

    Time frame: at 3rd month

    Measured by snellen chart

  4. Best corrected visual acuity

    Time frame: at 6th month

    Measured by snellen chart

  5. Central macular thickness

    Time frame: at 1st month

    Measured by Optical coherence tomography (OCT)

  6. Central macular thickness

    Time frame: at 3rd month

    Measured by Optical coherence tomography (OCT)

  7. Central macular thickness

    Time frame: at 6th month

    Measured by Optical coherence tomography (OCT)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 26, 2022
Registry last updated
Apr 26, 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.

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