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Retina Associates - Research Coordinators
 
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» RESEARCH & CLINICAL TRIALS

Study Detail: Genentech RIDE

Trial Description Summary : This is a study for diabetics (type 1 or 2) who are also experiencing diabetes related macular edema. The study medication is given by injection on a monthly basis to evaluate safety & effectivness of the study drug in stopping the macular edema and improving vision.

Basic Trial Information

Phase

Disease

Status

Age

Sponsor

Protocol #

III

Diabetic Macular Edema

Pending

18 yrs or more

Genentech

FVF4168g

Study Duration: Three (3) years and one month

Eligibility Criteria:

Inclusion Criteria

· Age 18 yrs or greater

· Type 1 or Type 2 diabetic

· Diagnosed with Diabetic Macular Edema (DME) for 2 years or less

· Acceptable vision ranging from 20/40 to 23/320

· Not pregnant or breastfeeding & willing to use acceptable form of birth control if able to become pregnant

· Please contact clinical coordinator for other inclusion criteria

Exclusion Criteria

· No history of surgery in the study eye

· No proliferative diabetic retinopathy (PDR) in the study eye

· Retinal ischemia in 500 microns of foveal center on FA

· Multiple specific exclusion criteria. Please contact clinical coordinator for more information

Study Title : A Phase III, double-masked, multicenter, randomized, sham-controlled study of the efficacy and safety of ranibizumab injection in subjects with clinically significant macular edema with center involvement secondary to diabetes mellitus

Trial Contact Information

Site

Study Coordinator

Beachwood

Dianne H. 216-831-5704 ext. 6800