Formulated PSTA Injection Versus PATA Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions
Formulated Posterior Subtenon Triamcinolone (PSTA) Injection Versus Posterior Subtenon Triamcinolone Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2022
CompletedFirst Submitted
Initial submission to the registry
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
May 23, 2022
CompletedMay 26, 2022
May 1, 2022
2.3 years
May 18, 2022
May 21, 2022
Conditions
Outcome Measures
Primary Outcomes (8)
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
Baseline
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
at 1st month
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
at 3rd month
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
at 6th month
central macular thickness ( CMT)
CMT will be measured with OCT
at baseline
central macular thickness ( CMT)
CMT will be measured with OCT
at 1st month
central macular thickness ( CMT)
CMT will be measured with OCT
at 3rd month
central macular thickness ( CMT)
CMT will be measured with OCT
at 6th month
Study Arms (2)
Formulated Posterior Sub Tenon Triamcinolone
ACTIVE COMPARATORPosterior Sub Tenon Triamcinolone alone
ACTIVE COMPARATORInterventions
formulated with sodium hyaluronate and chondroitin sulfate
Triamcinolone Acetonide alone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ehab tharwat
Damietta, New Damietta, 34517, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 18, 2022
First Posted
May 23, 2022
Study Start
January 2, 2020
Primary Completion
May 1, 2022
Study Completion
May 10, 2022
Last Updated
May 26, 2022
Record last verified: 2022-05