Squalamine for the Treatment in Proliferative Diabetic Retinopathy

February 9, 2015 updated by: Elman Retina Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Elman Retina Group, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion with complete regression of neovascularization on fundus photography at one month
Time Frame: 1 Month
1 Month

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Change in Visual Acuity from Baseline to 5 Months
Time Frame: 5 months
5 months

Other Outcome Measures

Outcome Measure
Time Frame
Proportion with partial regression of neovascularization on fundus photography
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elman Retina Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (ESTIMATE)

January 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ohr-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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