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Intravitreal Infliximab for Diabetic Macular Edema
NCT00959725Phase 2
Key facts
- Status
- Unknown
- Start
- Aug 2009
- Primary completion
- Aug 2011
- Countries
- 1
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Modality
- Monoclonal Antibodies
- Drugs
- infliximab
- Conditions
- diabetic macular edema (DME)
01
Overview
Phase 2, open-label, single-arm trial of infliximab in diabetic macular edema (DME), sponsored by Icahn School of Medicine at Mount Sinai. Primary endpoint: Best-Corrected Visual Acuity at 3 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Intravitreal infliximab
Single injection of intravitreal infliximab (2.0mg/0.05ml)
03
Who it enrols
Adult patients with diabetic macular edema (DME) refractory to or not amenable to laser photocoagulation, with central macular thickness >= 250 microns and visual acuity between 20/40 and hand motions. Patients with proliferative diabetic retinopathy, prior vitrectomy, or recent ocular surgery/injections are excluded.
04
Endpoints
Primary
Best-Corrected Visual Acuity
Secondary
Macular Thickness
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