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

Primary Purpose

Retinal Vein Occlusion

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Triamcinolone Acetonide

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Akram Fekry Elgazzar

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Formulated Posterior Sub Tenon Triamcinolone

Arm Description

All the eyes received single dose 40 mg of Triamcinolone Acetonide (TA) and VISCOAT which is 20 mg sodium chondroitin sulphate and 15 mg sodium hyaluronate (0.5 ml) through posterior subtenon route using NAGATA subtenon canula.

Outcomes

Primary Outcome Measures

Best corrected visual acuity

Measured by snellen chart

Best corrected visual acuity

Measured by snellen chart

Best corrected visual acuity

Measured by snellen chart

Best corrected visual acuity

Measured by snellen chart

Central macular thickness

Measured by Optical coherence tomography (OCT)

Central macular thickness

Measured by Optical coherence tomography (OCT)

Central macular thickness

Measured by Optical coherence tomography (OCT)

Secondary Outcome Measures

Full Information

NCT ID

NCT05345808

First Posted

April 14, 2022

Last Updated

April 21, 2022

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT05345808

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

February 20, 2022 (Actual)

Study Completion Date

March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Vein Occlusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Formulated Posterior Sub Tenon Triamcinolone

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide

Intervention Description

Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate

Primary Outcome Measure Information:

Title

Best corrected visual acuity

Description

Measured by snellen chart

Time Frame

at the base line

Title

Best corrected visual acuity

Description

Measured by snellen chart

Time Frame

at 1st month

Title

Best corrected visual acuity

Description

Measured by snellen chart

Time Frame

at 3rd month

Title

Best corrected visual acuity

Description

Measured by snellen chart

Time Frame

at 6th month

Title

Central macular thickness

Description

Measured by Optical coherence tomography (OCT)

Time Frame

at 1st month

Title

Central macular thickness

Description

Measured by Optical coherence tomography (OCT)

Time Frame

at 3rd month

Title

Central macular thickness

Description

Measured by Optical coherence tomography (OCT)

Time Frame

at 6th month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Akram Fekry Elgazzar

City

Damietta

ZIP/Postal Code

34517

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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