Retinal NeovascularizationPhase 2NCT01769183
Squalamine for the Treatment in Proliferative Diabetic Retinopathy
A Phase 2 study testing Squalamine Lactate ophthalmic solution 0.2% in people with Retinal Neovascularization, run by Elman Retina Group at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Neovascularization
- What is being tested?
- Squalamine Lactate ophthalmic solution 0.2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Retinal Neovascularization
- Being tested
- Squalamine Lactate ophthalmic solution 0.2%
- Keywords
- Proliferative Diabetic Retinopathy
- Medical subject headings
- Retinal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squalamine Lactate ophthalmic solution 0.2%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Squalamine | Experimental | 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. Receives: Drug: Squalamine Lactate ophthalmic solution 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion with complete regression of neovascularization on fundus photography at one month
Measured: 1 Month
Secondary outcomes (1)
Mean Change in Visual Acuity from Baseline to 5 Months
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal NeovascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elman Retina Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769183
- Sponsor's protocol ID
- Ohr-003
- Status last verified
- Feb 2015
- First submitted
- 14 Jan 2013
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Squalamine in the Treatment of Retinal Neovascularization From Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01769183
- Acronym / sponsor ID
- Ohr-003
- Conditions
- Retinal Neovascularization
- Keywords
- Proliferative Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Elman Retina GroupUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Squalamine | Experimental | Drug: Squalamine Lactate ophthalmic solution 0.2%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Squalamine |
Primary outcome
Proportion with complete regression of neovascularization on fundus photography at one month
Time frame: 1 Month
1 secondary outcome
Mean Change in Visual Acuity from Baseline to 5 Months
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Squalamine Lactate ophthalmic solution 0.2% in people with Retinal Neovascularization, run by Elman Retina Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion with complete regression of neovascularization on fundus photography at one month (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.