Squalamine for the Treatment in Proliferative Diabetic Retinopathy

Launched by ELMAN RETINA GROUP · Jan 15, 2013

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Eligibility criteria

• Inclusion Criteria:
• • Age \>= 18 years
• • Individuals \<18 years old are not being included because PDR is so rare in this age group that the diagnosis of PDR may be questionable.
• • Diagnosis of diabetes mellitus (type 1 or type 2)
• * Any one of the following will be considered to be sufficient evidence that diabetes is present:
• • Current regular use of insulin for the treatment of diabetes
• • Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
• • Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions)
• • At least one eye meets the study eye criteria
• • Able and willing provide informed consent
• Exclusion Criteria:
• • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
• • A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• • Individuals in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
• • Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.
• • Note: study participants cannot receive another investigational drug while participating in the study.
• • Known allergy to any component of the study drug.
• • Blood pressure \> 180/110 (systolic above 180 or diastolic above 110).
• • If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
• • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
• • Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
• • These drugs should not be used during the study.
• • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
• • Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
• • Individual is expecting to move out of the area of the clinical center during the study.
• • History of allergy to Squalamine