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NCT07870226
Suprachoroidal Triamcinolone Acetonide Monotherapy in Treatment-naive Center Involving Diabetic Macular Edema
Conditions: Diabetic Macular Edema
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 25
Sponsor: Khyber Girls Medical College
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. 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.
Eligibility Criteria
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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Source: ClinicalTrials.gov (NCT07870226). StuddyBuddy aggregates publicly available trial information.