Macula EdemaNCT05385562
Formulated PSTA Injection Versus PATA Alone in the Management of Macular Edema Secondary to Non-ischemic Retinal Vein Occlusions
A study testing Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate and Triamcinolone Acetonide alone in people with Macula Edema, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Macula Edema
- What is being tested?
- Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate and Triamcinolone Acetonide alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2020to 10 May 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Macular ischemia
- Iris neovascularisation
- patients with intravitreal injection of anti VEGFs, steroid, or any intraocular surgery 3 months prior to the inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Macula Edema
- Being tested
- Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate, Triamcinolone Acetonide alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfateDrug
formulated with sodium hyaluronate and chondroitin sulfate
Triamcinolone Acetonide aloneDrug
Triamcinolone Acetonide alone
| Study group | Role | What they receive |
|---|---|---|
| Formulated Posterior Sub Tenon Triamcinolone | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate |
| Posterior Sub Tenon Triamcinolone alone | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
Measured: Baseline
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
Measured: at 1st month
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
Measured: at 3rd month
Best-corrected visual acuity (BCVA)
will be measured with the Snellen chart
Measured: at 6th month
central macular thickness ( CMT)
CMT will be measured with OCT
Measured: at baseline
central macular thickness ( CMT)
CMT will be measured with OCT
Measured: at 1st month
central macular thickness ( CMT)
CMT will be measured with OCT
Measured: at 3rd month
central macular thickness ( CMT)
CMT will be measured with 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 posted23 May 2022
- Study start2 Jan 2020
- Primary completion1 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macula EdemaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab tharwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385562
- Sponsor's protocol ID
- PSTA and macular edema
- Status last verified
- May 2022
- First submitted
- 18 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05385562
- Acronym / sponsor ID
- PSTA and macular edema
- Conditions
- Macula Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 23 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formulated Posterior Sub Tenon Triamcinolone | Active comparator | Drug: Triamcinolone Acetonide and sodium hyaluronate and chondroitin sulfate |
| Posterior Sub Tenon Triamcinolone alone | Active comparator | Drug: Triamcinolone Acetonide alone |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Unwilling to participate in the study.
- Ischemic RVO
- Prior laser treatment
- Glaucoma/Ocular Hypertension
- Cataract which lead to difficulty in the evaluation of macula
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 Acetonide and sodium hyaluronate and chondroitin sulfateformulated with sodium hyaluronate and chondroitin sulfate | Drug | Formulated Posterior Sub Tenon Triamcinolone |
| Triamcinolone Acetonide aloneTriamcinolone Acetonide alone | Drug | Posterior Sub Tenon Triamcinolone alone |
Primary outcome
Best-corrected visual acuity (BCVA)
Time frame: Baseline
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA)
Time frame: at 1st month
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA)
Time frame: at 3rd month
will be measured with the Snellen chart
Best-corrected visual acuity (BCVA)
Time frame: at 6th month
will be measured with the Snellen chart
central macular thickness ( CMT)
Time frame: at baseline
CMT will be measured with OCT
central macular thickness ( CMT)
Time frame: at 1st month
CMT will be measured with OCT
central macular thickness ( CMT)
Time frame: at 3rd month
CMT will be measured with OCT
central macular thickness ( CMT)
Time frame: at 6th month
CMT will be measured with 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 May 2022.
- Individual participant dataSharing planned: Undecided
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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 and sodium hyaluronate and chondroitin sulfate and Triamcinolone Acetonide alone in people with Macula Edema, 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 May 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 (BCVA) (time frame: Baseline). The study lists 8 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 May 2022.