Squalamine for the Treatment in 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