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

Retinal Vein Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345808
• Other study ID #: PSTA in macular edema
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 30, 2022

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 30, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

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

Locations

Country	Name	City	State
Egypt	Akram Fekry Elgazzar	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	Measured by snellen chart	at the base line
Primary	Best corrected visual acuity	Measured by snellen chart	at 1st month
Primary	Best corrected visual acuity	Measured by snellen chart	at 3rd month
Primary	Best corrected visual acuity	Measured by snellen chart	at 6th month
Primary	Central macular thickness	Measured by Optical coherence tomography (OCT)	at 1st month
Primary	Central macular thickness	Measured by Optical coherence tomography (OCT)	at 3rd month
Primary	Central macular thickness	Measured by Optical coherence tomography (OCT)	at 6th month