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Home > "P" Clinical Trials Conditions > Phase II Study of anti-VEGF in Diabetic Macular Edema  Phase II Study of anti-VEGF in Diabetic Macular Edema
Phase II Study of anti-VEGF in Diabetic Macular Edema
For Condition: Diabetic Macular Edema
Status: Recruiting
Sponsor(s): Eyetech Pharmaceuticals ,
Synopsis: The purpose of this study is to establish the safe and efficacious dose of EYE001 when given as intravitreous injections in comparison to placebo injections.
Details: Diabetes Mellitus (DM) is an abnormality of blood glucose metabolism due to either, reduced insulin production or, altered insulin activity. Approximately 15% of the 15 million diabetics in the USA have Insulin-dependent diabetes mellitus (IDDM), or type I diabetes and are diagnosed before the age of 40. However, the majority of patients are diagnosed after this age with non-insulin dependent diabetes mellitus (NIDDM), or the type II form. DM results in numerous long-term systemic complications including Diabetic Retinopathy (DR). DR is broadly classified as either, non-proliferative diabetic retinopathy (NPDR), or proliferative diabetic retinopathy (PDR). The differentiation is based on the presence (PDR) or absence (NPDR) of new or abnormal retinal blood vessels. While those with type I DM experience a very high incidence of severe ocular complications, it is the type II group who makes up the vast majority of cases with diabetic eye disease simply because of their overall larger numbers (in excess of 12 million in the USA alone) [1]. There is no proven effective therapy for the treatment of DME in patients who have failed to respond to laser therapy. Laser or other surgical modalities can help minimize the risk of moderate or severe vision loss. Despite the benefit of focal laser photocoagulation for CSME, there are significant numbers of patients who either fail to respond to, or relapse following, this intervention. One of the biological activities of VEGF is to increase vascular permeability through specific binding to receptors on vascular endothelial cells. Among the angiogenic growth factors, VEGF is unique in terms of its vascular permeability enhancement, selective endothelial cell mitogenic activity, regulation by hypoxia, advanced glycation end products, insulin-like growth factor, reactive oxygen intermediates, and secretion by most tumor cells. Thus, EYE001 (anti-VEGF pegylated aptamer) could play a significant role in an ocular disease such as DME by inhibiting vascular leakage.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Patients of either gender, aged 18 years or above, diagnosed with clinically significant diabetic macular edema, with best-corrected visual acuity equal to, or worse than 68 ETDRS letters (20/50+3) but no worse than 25 letters (>20/320) in the study eye, and better than or equal to 5 ETDRS letters (>20/800) in the fellow eye may be enrolled. Women of childbearing potential will use two effective forms of contraception throughout the duration of the study.
Total Enrollment: 176
Location and Contact Information:
Foundation for Fighting Blindness *Recruiting*
Baltimore, Maryland,
United States
Recruiting Foundation Fighting Blindness 410-568-0150
Additional Information:
Study ID Numbers: EOP1005;
Study Start Date: June 2002
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040313
Other Diabetic Macular Edema Studies:
1. A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema
2. Phase II Study of anti-VEGF in Diabetic Macular Edema
Related Studies:
Other Diabetic Macular Edema Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Phase II Study of anti-VEGF in Diabetic Macular Edema
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