Retinal Vein OcclusionNCT05345808
Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions
A study testing Triamcinolone Acetonide in people with Retinal Vein Occlusion, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- Triamcinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Respiratory diseases need treatment with antibiotics
- Suffering from other chronic diseases as diabetes
- Patient with allergy from triamcinolone acetonide.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Retinal Vein Occlusion
- Being tested
- Triamcinolone Acetonide
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate
| Study group | Role | What they receive |
|---|---|---|
| Formulated Posterior Sub Tenon Triamcinolone | Other | 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. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Measured by snellen chart
Measured: at the base line
Best corrected visual acuity
Measured by snellen chart
Measured: at 1st month
Best corrected visual acuity
Measured by snellen chart
Measured: at 3rd month
Best corrected visual acuity
Measured by snellen chart
Measured: at 6th month
Central macular thickness
Measured by Optical coherence tomography (OCT)
Measured: at 1st month
Central macular thickness
Measured by Optical coherence tomography (OCT)
Measured: at 3rd month
Central macular thickness
Measured by Optical coherence tomography (OCT)
Measured: at 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Mar 2021
- Primary completion20 Feb 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akram Fekry Elgazzar, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345808
- Sponsor's protocol ID
- PSTA in macular edema
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions
- ClinicalTrials.gov ID
- NCT05345808
- Acronym / sponsor ID
- PSTA in macular edema
- Conditions
- Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Formulated Posterior Sub Tenon Triamcinolone | Other | Drug: Triamcinolone AcetonideAll 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. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone AcetonideTriamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate | Drug | Formulated Posterior Sub Tenon Triamcinolone |
Primary outcome
Best corrected visual acuity
Time frame: at the base line
Measured by snellen chart
Best corrected visual acuity
Time frame: at 1st month
Measured by snellen chart
Best corrected visual acuity
Time frame: at 3rd month
Measured by snellen chart
Best corrected visual acuity
Time frame: at 6th month
Measured by snellen chart
Central macular thickness
Time frame: at 1st month
Measured by Optical coherence tomography (OCT)
Central macular thickness
Time frame: at 3rd month
Measured by Optical coherence tomography (OCT)
Central macular thickness
Time frame: at 6th month
Measured by Optical coherence tomography (OCT)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide in people with Retinal Vein Occlusion, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: at the base line). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.