MedPath

Intravitreal injection of methotrexate in persistent diabetic macular edema

Phase 2
Conditions
Resistant macular edema in diabetic patients.
Distrubtion of retinal layers due to edema
Registration Number
IRCT201610098983N2
Lead Sponsor
Guilan University of Medical Sciences,Vice chancellor for research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
42
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in macular thickness. Timepoint: 1, 3 and 6 months after injection. Method of measurement: OCT.
Secondary Outcome Measures
NameTimeMethod
Change in visual acuity. Timepoint: 1, 3 and 6 months after injection. Method of measurement: Snellen chart.
© Copyright 2025. All Rights Reserved by MedPath