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

NCT ID: NCT05385562

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2022-05-10

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.

Conditions

Macula Edema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Formulated Posterior Sub Tenon Triamcinolone

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate

Intervention Type: DRUG

formulated with sodium hyaluronate and chondroitin sulfate

Posterior Sub Tenon Triamcinolone alone

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide alone

Intervention Type: DRUG

Triamcinolone Acetonide alone

Interventions

Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate

formulated with sodium hyaluronate and chondroitin sulfate

Intervention Type: DRUG

Triamcinolone Acetonide alone

Triamcinolone Acetonide alone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Ehab tharwat

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ehab tharwat

Damietta, New Damietta, Egypt

Countries

Egypt

Other Identifiers

PSTA and macular edema

Identifier Type: -

Identifier Source: org_study_id