Squalamine for the Treatment in Proliferative Diabetic Retinopathy

Retinal Neovascularization Clinical Trial

Official title:

Topical Squalamine in the Treatment of Retinal Neovascularization From Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769183
• Other study ID #: Ohr-003
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2013
• Last updated: February 9, 2015
• Start date: February 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Elman Retina Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Neovascularization, Pathologic
• Retinal Diseases
• Retinal Neovascularization

Intervention

Drug:
• Squalamine Lactate ophthalmic solution 0.2%
Patients will start with Squalamine one drop twice daily to the affected eye. If at one week the neovascularization shows no sign of regression, then the dose will be doubled to four times daily with a follow up at one day and one week following the increased dose frequency, then resuming the schedule at four weeks. If neovascularization returns within the study, the dose will be doubled to four times daily. In that case, a one day and one week visit will be added after increasing the dose. Squalamine treatment will discontinue after the week 20 visit.

Locations

Country	Name	City	State
United States	Elman Retina Group, P.A.	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Elman Retina Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion with partial regression of neovascularization on fundus photography		1 month	Yes
Primary	Proportion with complete regression of neovascularization on fundus photography at one month		1 Month	Yes
Secondary	Mean Change in Visual Acuity from Baseline to 5 Months		5 months	Yes