Diabetic Macular EdemaPhase 2SCTA CI-DMENCT07870226
Suprachoroidal Triamcinolone Acetonide Monotherapy in Treatment-naive Center Involving Diabetic Macular Edema
A Phase 2 study testing Suprachoroidal triamcinolone acetonide injection in people with Diabetic Macular Edema, run by Khyber Girls Medical College.
Trial summary
The goal of this clinical trial is to evaluate whether a single injection of suprachoroidal triamcinolone acetonide (SCTA) improves visual outcomes in patients with treatment-naive diabetic macular edema involving the center of the macula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- 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
- 25 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to Jun 2027
- Phase
- Phase 2
- 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
Inclusion Criteria: adults aged ≥18 years with type 1 or type 2 diabetes mellitus and center-involving diabetic macular edema (DME), with best-corrected visual acuity (BCVA) between 6/12 and 6/60 (Snellen), central subfield thickness (CST) >320 µm on OCT macula (Spectralis SD-OCT), and diabetic retinopathy severity no worse than severe non-proliferative diabetic retinopathy (NPDR). The study eye must be treatment-naive, with no prior anti-VEGF therapy, intravitreal or periocular steroid, or focal/grid laser for DME.
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Exclusion Criteria: any other ocular disease compromising visual acuity (e.g., retinal vein occlusion, age-related macular degeneration, retinal detachment, uveitis, or vitreomacular traction/epiretinal membrane contributing to edema); a history of glaucoma, current use of IOP-lowering medication, or baseline IOP >21 mmHg; any intraocular surgery within the preceding 3 months; panretinal photocoagulation for severe NPDR or proliferative DR within the preceding 3 months; media opacity precluding reliable OCT imaging or fundus examination; a history of significant steroid-response IOP rise; or pregnancy/breastfeeding.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Outcomes of Suprachoroidal Triamcinolone Acetonide Monotherapy in Treatment-Naïve Center-Involving Diabetic Macular Edema
The goal of this clinical trial is to evaluate whether a single injection of suprachoroidal triamcinolone acetonide (SCTA) improves visual outcomes in patients with treatment-naive diabetic macular edema involving the center of the macula. The study will also evaluate the safety of SCTA by monitoring for possible side effects, including an increase in intraocular pressure and cataract progression.
Patients will be evaluated at the start of the study (baseline) and will receive one injection of SCTA. They will then be followed at 1, 3, and 6 months. At each follow-up visit, visual acuity, central macular thickness, intraocular pressure, and cataract status will be assessed to evaluate the effectiveness and safety of the treatment.
- Conditions
- Diabetic Macular Edema
- Being tested
- Suprachoroidal triamcinolone acetonide injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprachoroidal triamcinolone acetonide injectionDrug
4mg/0.1 ml, given once at baseline
| Study group | Role | What they receive |
|---|---|---|
| SCTA monotherapy | Experimental | SCTA monotherapy Receives: Drug: Suprachoroidal triamcinolone acetonide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BCVA(logMAR) from baseline to 6 months
whether there is improvement in Visual acuity after SCTA
Measured: from enrollment of participants to final outcome measurement at 6 month
change in Visual acuity
measured in logMAR
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start21 Sep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Girls Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870226
- Sponsor's protocol ID
- CHR-IREB-2026-0070
- Acronym
- SCTA CI-DME
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in results
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Suprachoroidal Triamcinolone Acetonide Monotherapy in Treatment-Naïve Center-Involving Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT07870226
- Acronym / sponsor ID
- SCTA CI-DME / CHR-IREB-2026-0070
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Khyber Girls Medical CollegeUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Oct 2026 (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 clinical trial is to evaluate whether a single injection of suprachoroidal triamcinolone acetonide (SCTA) improves visual outcomes in patients with treatment-naive diabetic macular edema involving the center of the macula. The study will also evaluate the safety of SCTA by monitoring for possible side effects, including an increase in intraocular pressure and cataract progression.
Patients will be evaluated at the start of the study (baseline) and will receive one injection of SCTA. They will then be followed at 1, 3, and 6 months. At each follow-up visit, visual acuity, central macular thickness, intraocular pressure, and cataract status will be assessed to evaluate the effectiveness and safety of the treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCTA monotherapy | Experimental | Drug: Suprachoroidal triamcinolone acetonide injectionSCTA monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 injection4mg/0.1 ml, given once at baseline | Drug | SCTA monotherapy |
Primary outcome
Change in BCVA(logMAR) from baseline to 6 months
Time frame: from enrollment of participants to final outcome measurement at 6 month
whether there is improvement in Visual acuity after SCTA
change in Visual acuity
Time frame: from baseline to 6 months
measured in logMAR
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 13 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD used in results
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suprachoroidal triamcinolone acetonide injection in people with Diabetic Macular Edema, run by Khyber Girls Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Saima Farooq, MBBS, FCPS (+923339977188, saaima_farooq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BCVA(logMAR) from baseline to 6 months (time frame: from enrollment of participants to final outcome measurement at 6 month). The study lists 2 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 13 Oct 2026.