Baltimore, Maryland 21237

  • Retinal Neovascularization


The purpose of this study is to determine the efficacy in the use of topical Squalamine Lactate Ophthalmic Solution, 0.2% in the treatment of retinal neovascularization resulting from proliferative diabetic retinopathy.


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



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Baltimore, Maryland 21237
United States

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Site Status: N/A

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Date Processed: June 18, 2021

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