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

Primary Purpose

Macula Edema

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate
Triamcinolone Acetonide alone
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macula Edema

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ehab tharwat

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Formulated Posterior Sub Tenon Triamcinolone

Posterior Sub Tenon Triamcinolone alone

Arm Description

Outcomes

Primary Outcome Measures

Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
central macular thickness ( CMT)
CMT will be measured with OCT
central macular thickness ( CMT)
CMT will be measured with OCT
central macular thickness ( CMT)
CMT will be measured with OCT
central macular thickness ( CMT)
CMT will be measured with OCT

Secondary Outcome Measures

Full Information

First Posted
May 18, 2022
Last Updated
May 21, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05385562
Brief Title
Formulated PSTA Injection Versus PATA Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 10, 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
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formulated Posterior Sub Tenon Triamcinolone
Arm Type
Active Comparator
Arm Title
Posterior Sub Tenon Triamcinolone alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate
Intervention Description
formulated with sodium hyaluronate and chondroitin sulfate
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide alone
Intervention Description
Triamcinolone Acetonide alone
Primary Outcome Measure Information:
Title
Best-corrected visual acuity (BCVA)
Description
will be measured with the Snellen chart
Time Frame
Baseline
Title
Best-corrected visual acuity (BCVA)
Description
will be measured with the Snellen chart
Time Frame
at 1st month
Title
Best-corrected visual acuity (BCVA)
Description
will be measured with the Snellen chart
Time Frame
at 3rd month
Title
Best-corrected visual acuity (BCVA)
Description
will be measured with the Snellen chart
Time Frame
at 6th month
Title
central macular thickness ( CMT)
Description
CMT will be measured with OCT
Time Frame
at baseline
Title
central macular thickness ( CMT)
Description
CMT will be measured with OCT
Time Frame
at 1st month
Title
central macular thickness ( CMT)
Description
CMT will be measured with OCT
Time Frame
at 3rd month
Title
central macular thickness ( CMT)
Description
CMT will be measured with OCT
Time Frame
at 6th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ehab tharwat
City
Damieta
State/Province
New Damietta
ZIP/Postal Code
34517
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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