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Squalamine for the Treatment in Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT01769183
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Retinal Neovascularization Drug: Squalamine Lactate ophthalmic solution 0.2% Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Squalamine in the Treatment of Retinal Neovascularization From Proliferative Diabetic Retinopathy
Study Start Date : February 2013
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Squalamine
Study eyes will be assigned to receive Squalamine. The dose will be one drop twice daily. If neovascularization fails to regress at week one or if neovascularization returns within the study, the dose will be increased to four times daily. In that case, a one day and one week visit will be added after increasing the dose. Patients will continue administering study drug until week 20.
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.

Outcome Measures

Primary Outcome Measures :
  1. Proportion with complete regression of neovascularization on fundus photography at one month [ Time Frame: 1 Month ]

Secondary Outcome Measures :
  1. Mean Change in Visual Acuity from Baseline to 5 Months [ Time Frame: 5 months ]

Other Outcome Measures:
  1. Proportion with partial regression of neovascularization on fundus photography [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769183

United States, Maryland
Elman Retina Group, P.A.
Baltimore, Maryland, United States, 21237
Sponsors and Collaborators
Elman Retina Group
More Information

Responsible Party: Elman Retina Group
ClinicalTrials.gov Identifier: NCT01769183     History of Changes
Other Study ID Numbers: Ohr-003
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Elman Retina Group:
Proliferative Diabetic Retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Neovascularization, Pathologic
Retinal Neovascularization
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors