Macular Edema (ME)Early Phase 1NCT07145008
Suprachoroidal Triamcinolone in Macular Edema for Patients With Non-Infectious Uveitis Resistant to Subtenon Triamcinolon
A Early Phase 1 study testing Suprachoroidal triamcinolone acetonide injection in people with Macular Edema (ME) and Non Infectious Uveitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of this study is to learn if a suprachoroidal triamcinolone injection can treat vision-threatening swelling in the center of the retina (macular edema) caused by non-infectious uveitis, especially in people who did not improve after a standard steroid injection around the eye (sub-Tenon injection). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema (ME), Non Infectious Uveitis
- What is being tested?
- Suprachoroidal triamcinolone acetonide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2024to 1 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-infectious uveitis complicated with macular edema
- Uveitic macular edema of less than four months' duration
- Macular edema persisted despite lack of intra-ocular inflammation
- No response to posterior sub-Tenon triamcinolone acetonide injections
Who cannot join
- Those with epiretinal membrane-associated macular edema
- Below 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
Ibn Al-Haitham Eye Teaching Hospital
Baghdad, 10064
Mohammed Suhail Al-Salam, +964 790 183 6367, mohammedsuhail@uomustansiriyah.edu.iq
About this study
The goal of this study is to learn if a suprachoroidal triamcinolone injection can treat vision-threatening swelling in the center of the retina (macular edema) caused by non-infectious uveitis, especially in people who did not improve after a standard steroid injection around the eye (sub-Tenon injection).
The main questions it aims to answer are:
Read more
Does vision improve on the eye chart after the injection?
Does the injection lower retinal swelling (reduction in thickness) within 3 months?
Participants will:
Have a pre-treatment check (vision test, slit-lamp exam, and a retinal scan called OCT).
Receive one suprachoroidal triamcinolone injection under anesthetics drops in a sterile setting (operating room) with standard monitoring.
Return for visits about 1 month and 3 months after treatment for repeat vision tests, and OCT scans.
Contact the clinic if they notice pain, redness, new floaters, or worsening vision.
- Conditions
- Macular Edema (ME), Non Infectious Uveitis
- Being tested
- Suprachoroidal triamcinolone acetonide injection
- Keywords
- Suprachoroidal Triamcinolone, Macular Edema, Non infectious uveitis, Subtenon resistant
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprachoroidal triamcinolone acetonide injectionDrug
For suprachoroidal injection, we developed a custom-made delivery system to access the potential suprachoroidal space. A 1 mL tuberculin syringe fitted with a 27-gauge needle was prepared, and a plastic sleeve from a 24-26 G IV cannula was placed over the needle as a spacer to control penetration depth.
| Study group | Role | What they receive |
|---|---|---|
| Suprachoroidal Triamcinolone treatment arm | Experimental | Not described Receives: Drug: Suprachoroidal triamcinolone acetonide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity improvement
visual acuity improvement was defined as a gain of two or more lines in visual acuity or a reduction in logMAR values
Measured: 3 months
Secondary outcomes (1)
Central Macular Thickness
A reduction in central macular thickness (CMT) exceeding 20%.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Sep 2024
- Primary completion1 Jun 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema (ME)Studies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mutar, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145008
- Sponsor's protocol ID
- 2024-234
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprachoroidal Triamcinolone in Macular Edema for Patients With Non-Infectious Uveitis Resistant to Subtenon Triamcinolon
- ClinicalTrials.gov ID
- NCT07145008
- Acronym / sponsor ID
- 2024-234
- Conditions
- Macular Edema (ME), Non Infectious Uveitis
- Keywords
- Suprachoroidal Triamcinolone, Macular Edema, Non infectious uveitis, Subtenon resistant
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Aug 2025 (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 goal of this study is to learn if a suprachoroidal triamcinolone injection can treat vision-threatening swelling in the center of the retina (macular edema) caused by non-infectious uveitis, especially in people who did not improve after a standard steroid injection around the eye (sub-Tenon injection).
The main questions it aims to answer are:
Does vision improve on the eye chart after the injection?
Does the injection lower retinal swelling (reduction in thickness) within 3 months?
Participants will:
Have a pre-treatment check (vision test, slit-lamp exam, and a retinal scan called OCT).
Receive one suprachoroidal triamcinolone injection under anesthetics drops in a sterile setting (operating room) with standard monitoring.
Return for visits about 1 month and 3 months after treatment for repeat vision tests, and OCT scans.
Contact the clinic if they notice pain, redness, new floaters, or worsening vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suprachoroidal Triamcinolone treatment arm | Experimental | Drug: Suprachoroidal triamcinolone acetonide injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-infectious uveitis complicated with macular edema
- Uveitic macular edema of less than four months' duration
- Macular edema persisted despite lack of intra-ocular inflammation
- No response to posterior sub-Tenon triamcinolone acetonide injections
Key exclusion criteria (2 listed)
- Those with epiretinal membrane-associated macular edema
- Below 18 years
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 |
|---|---|---|
| Suprachoroidal triamcinolone acetonide injectionFor suprachoroidal injection, we developed a custom-made delivery system to access the potential suprachoroidal space. A 1 mL tuberculin syringe fitted with a 27-gauge needle was prepared, and a plastic sleeve from a 24-26 G IV cannula was placed over the needle as a spacer to control penetration depth. | Drug | Suprachoroidal Triamcinolone treatment arm |
Primary outcome
Visual acuity improvement
Time frame: 3 months
visual acuity improvement was defined as a gain of two or more lines in visual acuity or a reduction in logMAR values
1 secondary outcome
Central Macular Thickness
Time frame: 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Suprachoroidal triamcinolone acetonide injection in people with Macular Edema (ME) and Non Infectious Uveitis, run by University of Baghdad at 1 site in Iraq.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. 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 Iraq. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Suhail Al-Salam (+964 790 183 6367, mohammedsuhail@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity improvement (time frame: 3 months). 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 28 Aug 2025.