Diabetic Macular Edema of Left EyeNCT05464953
Suprachoroidal Triamcinolone Versus Posterior Subtenon Triamcinolone Alone or Formulated in the Management of Diabetic Macular Edema.
A study testing Triamcinolone Acetonide and Formulated Triamcinolone in people with Diabetic Macular Edema of Left Eye, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision impairment and blindness worldwide. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Diabetic Macular Edema of Left Eye
- What is being tested?
- Triamcinolone Acetonide and Formulated Triamcinolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2020to 30 Apr 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diminution of vision due to diabetic macular edema.
- CMT ≥ 250 µ.
- Willing to participate in the study.
Who cannot join
- Unwilling to participate in the study, 2)
- 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, 7)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
Official title: Alazher University Dean
Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision impairment and blindness worldwide. Diabetic retinopathy (DR) is the most common retinal vascular disorder and is the leading cause of vision loss among patients aged 25 to 74 years.
Aim to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone versus suprachoroidal triamcinolone in the management of diabetic macular edema.
- Conditions
- Diabetic Macular Edema of Left Eye
- Being tested
- Triamcinolone Acetonide, Formulated Triamcinolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Triamcinolone Acetonide is a corticosteroid that has antiangiogenic and anti-inflammatory effects that can inhibit the expression of VEGF and other proinflammatory cytokines, improving best-corrected visual acuity and decreasing central retinal thickness (CRT) in patients with macular edema
Formulated TriamcinoloneDrug
Formulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate
| Study group | Role | What they receive |
|---|---|---|
| Formulated Posterior Sub Tenon Triamcinolone | Active comparator | Not described Receives: Drug: Formulated Triamcinolone |
| Posterior Sub Tenon Triamcinolone alone | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide |
| suprachoroidal Triamcinolone | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Best-corrected visual acuity
Measured: Base line
BCVA
Best-corrected visual acuity
Measured: at 1st month
BCVA
Best-corrected visual acuity
Measured: at 3rd month
BCVA
Best-corrected visual acuity
Measured: at 6th month
CMT
CENTRAL MACULAR THICKNESS
Measured: at baseline
CMT
CENTRAL MACULAR THICKNESS
Measured: at 1st month
CMT
CENTRAL MACULAR THICKNESS
Measured: at 3rd month
CMT
CENTRAL MACULAR THICKNESS
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 posted19 Jul 2022
- Study start20 Jan 2020
- Primary completion20 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema of Left EyeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT05464953
- Sponsor's protocol ID
- PSTA and DME
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alazher University Dean
- ClinicalTrials.gov ID
- NCT05464953
- Acronym / sponsor ID
- PSTA and DME
- Conditions
- Diabetic Macular Edema of Left Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Jul 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.
Background Retinal vascular disorders, such as diabetic retinopathy, hypertensive retinopathy, retinal hemorrhage, and retinal vein occlusion are significant causes of vision impairment and blindness worldwide. Diabetic retinopathy (DR) is the most common retinal vascular disorder and is the leading cause of vision loss among patients aged 25 to 74 years.
Aim to compare formulated Posterior Subtenon Triamcinolone acetonide (PSTA) injection versus Posterior Subtenon Triamcinolone acetonide alone versus suprachoroidal triamcinolone in the management of diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formulated Posterior Sub Tenon Triamcinolone | Active comparator | Drug: Formulated Triamcinolone |
| Posterior Sub Tenon Triamcinolone alone | Active comparator | Drug: Triamcinolone Acetonide |
| suprachoroidal Triamcinolone | Active comparator | Drug: Triamcinolone Acetonide |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diminution of vision due to diabetic macular edema.
- CMT ≥ 250 µ.
- Willing to participate in the study.
Key exclusion criteria (8 listed)
- Unwilling to participate in the study, 2)
- 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 is a corticosteroid that has antiangiogenic and anti-inflammatory effects that can inhibit the expression of VEGF and other proinflammatory cytokines, improving best-corrected visual acuity and decreasing central retinal thickness (CRT) in patients with macular edema | Drug | Posterior Sub Tenon Triamcinolone alone, suprachoroidal Triamcinolone |
| Formulated TriamcinoloneFormulated Triamcinolone: is triamcinolone and sodium hyaluronate and chondroitin sulfate | Drug | Formulated Posterior Sub Tenon Triamcinolone |
Primary outcome
BCVA
Time frame: Base line
Best-corrected visual acuity
BCVA
Time frame: at 1st month
Best-corrected visual acuity
BCVA
Time frame: at 3rd month
Best-corrected visual acuity
BCVA
Time frame: at 6th month
Best-corrected visual acuity
CMT
Time frame: at baseline
CENTRAL MACULAR THICKNESS
CMT
Time frame: at 1st month
CENTRAL MACULAR THICKNESS
CMT
Time frame: at 3rd month
CENTRAL MACULAR THICKNESS
CMT
Time frame: at 6th month
CENTRAL MACULAR THICKNESS
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 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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 Formulated Triamcinolone in people with Diabetic Macular Edema of Left Eye, 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 8 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 19 Jul 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?
BCVA (time frame: Base line). 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 19 Jul 2022.