Back to resultsSqualamine for the Treatment in Proliferative Diabetic Retinopathy
Primary Purpose
Retinal Neovascularization
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Squalamine Lactate ophthalmic solution 0.2%
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Neovascularization focused on measuring 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
Sites / Locations
- Elman Retina Group, P.A.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Squalamine
Arm Description
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.
Outcomes
Primary Outcome Measures
Proportion with complete regression of neovascularization on fundus photography at one month
Secondary Outcome Measures
Mean Change in Visual Acuity from Baseline to 5 Months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01769183
Brief Title
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
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elman Retina Group
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Neovascularization
Keywords
Proliferative Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Squalamine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Squalamine Lactate ophthalmic solution 0.2%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion with complete regression of neovascularization on fundus photography at one month
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Mean Change in Visual Acuity from Baseline to 5 Months
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Proportion with partial regression of neovascularization on fundus photography
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Elman Retina Group, P.A.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Squalamine for the Treatment in Proliferative Diabetic Retinopathy
We'll reach out to this number within 24 hrs