IRCT20170303032845N1
Recruiting
Phase 3
The Comparison of the Efficacy of Intravitreal Injection of Iranian Made Ranibizumab (Vicentis®) with Imported Ranibizumab (Lucentis®) in Patients with Diabetic Macular Edema: A phase III, Two-armed, Double-blind, Parallel, Active-controlled, and Noninferiority Clinical Randomized Trial
Aracell zist daru0 sites154 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Aracell zist daru
- Enrollment
- 154
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diabetes mellitus type 1 or 2
- •Center involving macular edema with a central subfield thickness (CST) of \>300
- •Early treatment of Diabetic Retinopathy Study (ETDRS) best\-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400\)
- •Blood Pressure \<150/100
- •Triglyceride and LDL up to 20% higher than upper normal limits
- •Pseudophakic patients are allowed to enter the study.
- •Signed written inform consent
Exclusion Criteria
- •History of intravitreal injection within the past 2 months
- •History of any ocular surgery within the past 6 months
- •History of glaucoma or ocular hypertension
- •Any media opacity in the cornea, lens and vitreous body which interferes with eye examination and imaging.
- •Monocular patients
- •Pregnant or breastfeeding women
- •Proliferative diabetic retinopathy (PDR) with high\-risk characteristics
- •Smoking (more than 10 cigarettes per day)
- •Use of acetazolamide tablets or intraocular pressure\-lowering drops
- •Use of systemic corticosteroids or nonsteroidal anti\-inflammatory eye drops (NSAIDs)
Outcomes
Primary Outcomes
Not specified
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