Squalamine for the Treatment in Proliferative Diabetic Retinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Elman Retina Group
Sponsor:
Information provided by (Responsible Party):
Elman Retina Group
ClinicalTrials.gov Identifier:
NCT01769183
First received: January 14, 2013
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Retinal Neovascularization
Drug: Squalamine Lactate ophthalmic solution 0.2%
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical Squalamine in the Treatment of Retinal Neovascularization From Proliferative Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Elman Retina Group:

Primary Outcome Measures:
  • Proportion with complete regression of neovascularization on fundus photography at one month [ Time Frame: 1 Month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean Change in Visual Acuity from Baseline to 5 Months [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Proportion with partial regression of neovascularization on fundus photography [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769183

Locations
United States, Maryland
Elman Retina Group, P.A. Recruiting
Baltimore, Maryland, United States, 21237
Contact: Michael J Elman, MD    410-686-3000    elman@elmanretina.com   
Contact: Jennifer L Denton Belz    410-686-3000    belz@elmanretina.com   
Principal Investigator: Michael J Elman, MD         
Sub-Investigator: Robert Liss, MD         
Sponsors and Collaborators
Elman Retina Group
  More Information

No publications provided

Responsible Party: Elman Retina Group
ClinicalTrials.gov Identifier: NCT01769183     History of Changes
Other Study ID Numbers: Ohr-003
Study First Received: January 14, 2013
Last Updated: April 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Elman Retina Group:
Proliferative Diabetic Retinopathy

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

ClinicalTrials.gov processed this record on July 22, 2014