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
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.
-
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.
-
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