Treatment naived center-involved diabetic macular edema patients Biosimilar, Efficacy, Safety, Bevacizumab, ABP 215, Diabetic macular edema
Conditions
Interventions
Intravitreous injection 0.05 mg of drug monthly in the first 3 months then prn for the following 3 months (Total 6 month period),Intravitreous injection 0.05 mg of drug monthly in the first 3 months
Experimental Drug,Active Comparator Drug
ABP125,Bevacizumab
Sponsors
Rajavithi hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Type 1 or 2 diabetes mellitus 2. At least one eye compatible with criteria of the following -BCVA letter score 24-78 within 8 days after randomization -DME by eye examination -Central subfield thickness (CST) more than or equal to 250 micron from OCT -Clear all eye's media enough to take fundus photo -Size of pupil is big enough to take fundus photo 3. Participants have well-cooperated enough to take fundus photo 4. Ability to give consent in research
Exclusion criteria
Exclusion criteria: For general conditions 1. Severe comorbidities: Chronic kidney disease stage V, Hypertension (BP > 160/100), Myocardial infarction or Stoke within 3 months prior screening, Uncontrolled diabetes mellitus within 3 months prior screening (FBS > 180 mg/dL , HbA1C > 10%) 2. Pregnant or planned to pregnant in 1 year period following the treatment (Women participant who pregnant during study period will be withdrawned) 3. Breastfeeding women For study eye 1. Macular edema from other causes 2. Other eye conditions that not be able to achieve VA improvement after macular edema resolved ex. foveal atrophy 3. Other eye conditions that affect macular edema or VA apart from diabetes ex. uveitis 4. Evidence of cataract that explain VA more than or equal to 20/40 5. Received any anti-VEGF for any conditions within 12 months prior screening 6. Received focal or grid macular photocoagulation or intra-vitreous/periorbital steroid injection for DME treatment within 4 months prior screening 7. Undergone eye surgery (vitrectomy, cataract extraction, scleral buckle, any intraocular surgery etc.) within 4 months prior screening or plan to undergo within 6 months after screening 8. Undergone YAG capsulotomy within 2 months prior screening 9. Aphakic eye 10. Periorbital inflammation ex. conjuntivitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity At 6 months after end of treatment Letter score | — |
Secondary
| Measure | Time frame |
|---|---|
| Central subfield thickness At 6 months after end of treatment Micron,Complications Throughout treatment period Number of subjects for each complication | — |
Countries
Thailand
Contacts
Public ContactMongkol Tadarati
Ophthalmology department
Outcome results
None listed