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Clinical trial for evaluation of the effect of topical interferon a2b as a complementary treatment of macular edema of patients with diabetic retinopathy compared with placebo

Evaluation of the effect of topical interferon a2b as a complementary treatment of macular edema of patients with diabetic retinopathy in comparison with placebo, double blind randomized placebo controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016081529370N1
Enrollment
50
Registered
2016-10-26
Start date
2016-09-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

diabetic retinopathy. Diabetic retinopathy

Interventions

Intervention 1: Intervention group:The patients in this group receive topical Interferon alpha 2 b with dosage of 1 million unit per milliliter in the same container of placebo,4 times a day. one mill
Treatment - Drugs
Intervention group:The patients in this group receive topical Interferon alpha 2 b with dosage of 1 million unit per milliliter in the same container of placebo,4 times a day. one milliliter of Interf
Control group: The patients in this group receive artificial tear as placebo four times a day for 4 weeks and are examined on week 2,4 and 8 during study.

Sponsors

Vice chancellor for research of Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: patient with diabetic macular edema. Exclusion criteria: patients with positive history of radiotherapy or treatment with immunosuppressive agents; patients with malignancy or who have undergone organ transplant; patients with previous ocular vascular accident; patients who have had cataract surgery in the past 3 months.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Macular thickness. Timepoint: before intervention, 4 wks after start of intervention,4 wks after the end of intervention. Method of measurement: hidelberg OCT.;Visual acuity. Timepoint: before intervention, 4 wks after start of intervention. Method of measurement: snellen chart.

Secondary

MeasureTime frame
Leakage on fluorescein angiography. Timepoint: before intervention, 4 wks after start of intervention. Method of measurement: fluoresceine angiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAidin Meshksar

Shiraz University of Medical Sciences

meshksaray@sums.ac.ir+98 713671382

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026