Squalamine for the Treatment in Proliferative Diabetic Retinopathy

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Elman Retina Group
• Treatments: Ophthalmic Solutions; Squalamine

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