Comparison of intravitreal Bevacizumab (Avastin) injection alone or in combination with Diclofenac in the treatment of diabetic macular edema

The comparison of the effect of intravitreal Bevacizumab (Avastin) injection alone or in combination with Diclofenac on the visual acuity of patients with diabetic macular edema

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201512144786N3

Enrollment

Registered

2016-01-29

Start date

2014-11-21

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: The first group is treated by 1.25 milligrams in 0.1 milliliter Bevacizumab (Avastin) intravitreally. Intervention 2: The second group is treated by 1.25 milligrams in 0.1 milliliter B

Treatment - Drugs

The first group is treated by 1.25 milligrams in 0.1 milliliter Bevacizumab (Avastin) intravitreally.

The second group is treated by 1.25 milligrams in 0.1 milliliter Bevacizumab (Avastin) and 300 micrograms in 0.1 milliliter Diclofenac intravitreally.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with these criteria were enrolled: diagnosed as center involving diabetic macular edema (DME), have no history of previous surgery, intraocular injection, diagnosis of glaucoma or ocular hypertension, visual acuity between 20/320 to 20/40, absence of iris neovascularization and significant opacities of ocular media, who are not monocular and are not pregnant. The exclusion criteria were: any previous hypersensitivity reaction to Bevacizumab or Diclofenac, complications such as endophthalmitis or intraocular pressure rise, refusal of patient or his/her non-cooperation in follow ups.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Central macular thickness. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Optical coherence tomography.;Macular volume. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Optical coherence tomography.;Best corrected visual acuity. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Snellen chart.	—

Measure

Time frame

Central macular thickness. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Optical coherence tomography.;Macular volume. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Optical coherence tomography.;Best corrected visual acuity. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Snellen chart.

—

Secondary

Measure	Time frame
Refractive error. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Auto refractometer.;Intraocular pressure. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Goldmann tonometer.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Ali Sonbolestan

Isfahan University of Medical Sciences

sonbolestan@edc.mui.ac.ir+98 31 3445 2031

Outcome results

None listed

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