Suprachoroidal Triamcinolone Acetonide Monotherapy in Treatment-naive Center Involving Diabetic Macular Edema

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKhyber Girls Medical College

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Suprachoroidal triamcinolone acetonide injection

    Drug

    4mg/0.1 ml, given once at baseline

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: SCTA monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in BCVA(logMAR) from baseline to 6 months

whether there is improvement in Visual acuity after SCTA

Time frame
from enrollment of participants to final outcome measurement at 6 month
2

change in Visual acuity

measured in logMAR

Time frame
from baseline to 6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: