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

Macula Edema Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385562
• Other study ID #: PSTA and macular edema
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: May 10, 2022

Study information

• Verified date: May 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 10, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Macula Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate
formulated with sodium hyaluronate and chondroitin sulfate
• Triamcinolone Acetonide alone
Triamcinolone Acetonide alone

Locations

Country	Name	City	State
Egypt	Ehab tharwat	Damieta	New Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity (BCVA)	will be measured with the Snellen chart	Baseline
Primary	Best-corrected visual acuity (BCVA)	will be measured with the Snellen chart	at 1st month
Primary	Best-corrected visual acuity (BCVA)	will be measured with the Snellen chart	at 3rd month
Primary	Best-corrected visual acuity (BCVA)	will be measured with the Snellen chart	at 6th month
Primary	central macular thickness ( CMT)	CMT will be measured with OCT	at baseline
Primary	central macular thickness ( CMT)	CMT will be measured with OCT	at 1st month
Primary	central macular thickness ( CMT)	CMT will be measured with OCT	at 3rd month
Primary	central macular thickness ( CMT)	CMT will be measured with OCT	at 6th month