Effect of single dose suprachoroidal triamcinolone acetonide injection on diabetic macular edema.

To evaluate the effect of single dose suprachoroidal triamcinolone acetonide injection combined with three monthly intravitreal injection of bevacizumab on center-involving diabetic macular edema in patients with non-proliferative diabetic retinopathy compared to the control group.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200314046761N1

Enrollment

Registered

2020-03-21

Start date

2019-09-23

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Center-involving diabetic macular edema. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema.

Interventions

Intervention 1: Intervention group: Single dose suprachoroidal triamcinolone acetonide (4 mg / 0.1 cc) injection using custom made needle + intravitreal bevacizumab (1.25 mg / 0.05 cc) injections fo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with non-proliferative diabetic retinopathy with center-involving diabetic macular edema with best corrected visual acuity = 20/40. Patients have not received any interventions (Intravitreal injection, laser, intraocular surgery) 3 months prior to the recruitment. No history of deep vitrectomy.

Exclusion criteria

Exclusion criteria: Other comorbid conditions such as CNV, RVO, Glaucoma etc. Pregnancy Significant cataract

Design outcomes

Primary

Measure	Time frame
Mean change in best corrected visual acuity (BCVA). Timepoint: Baseline (Day 0), a month after third intravitreal injection (Day 90-95). Method of measurement: 1- Snellen chart 2- Early Treatment Diabetic Retinopathy Study (ETDRS) letters.	—

Secondary

Measure	Time frame
Mean changes in central macular thickness. Timepoint: Baseline (Day 0), a month after third intravitreal injection (Day 90-95). Method of measurement: Spectral domain optical coherence tomography.;Mean changes in central macular volume. Timepoint: Baseline (Day 0), a month after third intravitreal injection (Day 90-95). Method of measurement: Spectral domain optical coherence tomography.;Mean changes in intraocular pressure. Timepoint: Baseline (Day 0), day 30, a month after third intravitreal injection (Day 90-95). Method of measurement: Applanation tonometry.	—

Measure

Time frame

Mean changes in central macular thickness. Timepoint: Baseline (Day 0), a month after third intravitreal injection (Day 90-95). Method of measurement: Spectral domain optical coherence tomography.;Mean changes in central macular volume. Timepoint: Baseline (Day 0), a month after third intravitreal injection (Day 90-95). Method of measurement: Spectral domain optical coherence tomography.;Mean changes in intraocular pressure. Timepoint: Baseline (Day 0), day 30, a month after third intravitreal injection (Day 90-95). Method of measurement: Applanation tonometry.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Farhad Fazel, Dr.Mohammadreza Fazel

Esfahan University of Medical Sciences

mr.fazel90@gmail.com+98 31 3629 2656

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026