Clinical trial NCT01769183: Squalamine for the Treatment in Proliferative Diabetic Retinopathy
Official title: Topical Squalamine in the Treatment of Retinal Neovascularization From Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retinal Neovascularization
Keywords: Proliferative Diabetic Retinopathy
Lead sponsor: Elman Retina Group
Sponsor class: OTHER
First posted: 2013-01-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Proportion with complete regression of neovascularization on fundus photography at one month
timeFrame: 1 Month
Secondary outcomes:
measure: Mean Change in Visual Acuity from Baseline to 5 Months
timeFrame: 5 months
Other outcomes:
measure: Proportion with partial regression of neovascularization on fundus photography
timeFrame: 1 month
Locations:
city: Baltimore
country: United States
facility: Elman Retina Group, P.A.
state: Maryland
Study officials:
References: