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Completed

NCT Number: NCT05385562

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

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.

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Key information

Conditions

Macula Edema

Age range

40 year–80 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 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.

Treatment and study plan

Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate

Drug

formulated with sodium hyaluronate and chondroitin sulfate

Triamcinolone Acetonide alone

Drug

Triamcinolone Acetonide alone

Primary outcomes

  1. Best-corrected visual acuity (BCVA)

    Time frame: Baseline

    will be measured with the Snellen chart

  2. Best-corrected visual acuity (BCVA)

    Time frame: at 1st month

    will be measured with the Snellen chart

  3. Best-corrected visual acuity (BCVA)

    Time frame: at 3rd month

    will be measured with the Snellen chart

  4. Best-corrected visual acuity (BCVA)

    Time frame: at 6th month

    will be measured with the Snellen chart

  5. central macular thickness ( CMT)

    Time frame: at baseline

    CMT will be measured with OCT

  6. central macular thickness ( CMT)

    Time frame: at 1st month

    CMT will be measured with OCT

  7. central macular thickness ( CMT)

    Time frame: at 3rd month

    CMT will be measured with OCT

  8. central macular thickness ( CMT)

    Time frame: at 6th month

    CMT will be measured with OCT

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 23, 2022
Registry last updated
May 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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