Squalamine for the Treatment in Proliferative Diabetic Retinopathy

Completed · Phase 2

Conditions studied: Retinal Neovascularization

In brief

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.

Key facts

Study ID

NCT01769183

Run by

Elman Retina Group

People needed

6

Starts

2013-02-01

Expected to finish

2014-08-01

Last updated by the study team

2015-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Elman Retina Group, P.A. — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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