Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
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
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedFirst Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedApril 26, 2022
April 1, 2022
12 months
April 14, 2022
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
Best corrected visual acuity
Measured by snellen chart
at the base line
Best corrected visual acuity
Measured by snellen chart
at 1st month
Best corrected visual acuity
Measured by snellen chart
at 3rd month
Best corrected visual acuity
Measured by snellen chart
at 6th month
Central macular thickness
Measured by Optical coherence tomography (OCT)
at 1st month
Central macular thickness
Measured by Optical coherence tomography (OCT)
at 3rd month
Central macular thickness
Measured by Optical coherence tomography (OCT)
at 6th month
Study Arms (1)
Formulated Posterior Sub Tenon Triamcinolone
OTHERAll 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.
Interventions
Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Unwilling to participate in the study
- Ischemic RVO
- previous laser treatment
- Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akram Fekry Elgazzar
Damietta, 34517, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 26, 2022
Study Start
March 1, 2021
Primary Completion
February 20, 2022
Study Completion
March 30, 2022
Last Updated
April 26, 2022
Record last verified: 2022-04