Skip to content

Intravitreal injection of methotrexate in persistent diabetic macular edema

Evaluation of therapeutic effect intravitreal injection of methotrexate in persistent diabetic macular edema

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201610098983N2
Enrollment
42
Registered
2016-10-30
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

Resistant macular edema in diabetic patients. Distrubtion of retinal layers due to edema

Interventions

using of intra viteral injection of 400µg MTX in eyes with resistant diabetic macular edema ,BCVA ,central subfleid thickness and macular thickness will be recorded before and 1,3,and 6 months after
Treatment - Drugs

Sponsors

Guilan University of Medical Sciences,Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Patient with central subfleid thickness (CST) More than 250 micrometers. 2. Best corrected visual acuity 20/ 200 and more. 3.lack of one line improvement, at least, in best corrected visual acuity or at least 10% reduction in central subfield thickness after intravitreal injection of three consecutive Bevacizumab and one injection co-administration bevacizumab -triamcinolone every 4-6week intervalor 3 consecutive Bevacizumab every 4 -6 weeks plus macular photouagulation. 4. Lack of traction on the macula, which is identified on clinical examination and OCT 5. Patient who agree entering the study (consent form) Exclusion criteria : 1. Any previous intraocular surgery that was done in more than 1year ago 2. Any laser photocuagulation treatment in the past 4 months . 3. Need to any intraocular surgery, intraocular injection or laser photocoagulation in the follow-up period . 4. Any traction on the macula which is identified on clinical examination and OCT. 5. No control of blood pressure, blood sugar and blood lipid during study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Change in macular thickness. Timepoint: 1, 3 and 6 months after injection. Method of measurement: OCT.

Secondary

MeasureTime frame
Change in visual acuity. Timepoint: 1, 3 and 6 months after injection. Method of measurement: Snellen chart.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohammad rasoul Sabouri

Guilan University of Medical Sciences

r_sabouri2002@yahoo.com+98 13 3323 6886

Outcome results

None listed

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