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

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT05385562

Collaborator

(none)

Enrollment

Location

Arms

28.2

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Macula Edema	Drug: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate Drug: Triamcinolone Acetonide alone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 2, 2020

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

May 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Formulated Posterior Sub Tenon Triamcinolone	Drug: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate formulated with sodium hyaluronate and chondroitin sulfate
Active Comparator: Posterior Sub Tenon Triamcinolone alone	Drug: Triamcinolone Acetonide alone Triamcinolone Acetonide alone

Arm

Intervention/Treatment

Active Comparator: Formulated Posterior Sub Tenon Triamcinolone

Drug: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate

formulated with sodium hyaluronate and chondroitin sulfate

Active Comparator: Posterior Sub Tenon Triamcinolone alone

Drug: Triamcinolone Acetonide alone

Triamcinolone Acetonide alone

Outcome Measures

Primary Outcome Measures

Best-corrected visual acuity (BCVA) [Baseline]
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA) [at 1st month]
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA) [at 3rd month]
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA) [at 6th month]
will be measured with the Snellen chart
central macular thickness ( CMT) [at baseline]
CMT will be measured with OCT
central macular thickness ( CMT) [at 1st month]
CMT will be measured with OCT
central macular thickness ( CMT) [at 3rd month]
CMT will be measured with OCT
central macular thickness ( CMT) [at 6th month]
CMT will be measured with OCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.