Retinal Vein OcclusionPhase 1/2NCT02614937
Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion
A Phase 1/2 study testing ranibizumab and Squalamine Lactate Ophthalmic Solution, 0.2% in people with Retinal Vein Occlusion and Macular Edema, run by Ohr Pharmaceutical Inc..
Trial summary
This was a prospective, single center, open label, randomized study evaluating the biological effect of squalamine lactate ophthalmic solution, 0.2% combined with intravitreous ranibizumab in patients with macular edema secondary to branch, hemi-central and central retinal vein occlusion (BRVO, HRVO, CRVO). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Macular Edema
- What is being tested?
- ranibizumab and Squalamine Lactate Ophthalmic Solution, 0.2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2014
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eyes with treatment naïve, center involving macular edema secondary to BRVO, HRVO or CRVO in patients of at least 40 years of age
- Macular edema of 1-4 months duration prior to the baseline visit
- Best corrected baseline ETDRS visual acuity of 20/40 to 20/320 Snellen equivalent using the 4 meter testing method
- Baseline CST greater than or equal to 325uM using SD-OCT imaging
- Less than 50% foveal capillary ring disruption as defined by fluorescein angiography (FA)
- Absence of dense intraretinal or subretinal hemorrhage and or lipid through the foveal center
- Absence of subfoveal fibrosis or hyperpigmentation.
Who cannot join
- Eyes with ocular pathology other than RVO related macular edema such as clinically significant cataract or media opacity, diabetic retinopathy, macular degeneration, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or intraocular tumor
- Intraocular surgery within 6 months prior to baseline
- Two-plus or greater afferent pupillary defect (APD) in the study eye
- Likelihood of evidence driven indication for peripheral scatter photocoagulation within 6 months of recruitment
- History of previous intravitreal pharmacologic treatment of any kind in the study eye
- History of previous retinal laser photocoagulation of any kind in the study eye
Show all 9Show fewer
- History of intravitreal anti-VEGF therapy in the fellow eye within 6 months prior to baseline
- Any evidence of baseline ocular neovascularization such as disc neovascularization, preretinal neovascularization, iris or angle neovascularization in the study eye
- Eyes that have shown spontaneous improvement within the preceding 3 months defined as an improvement of best corrected visual acuity of greater than 15 ETDRS letters or thinning of the CST on OCT of greater than 20%
About this study
Official title: Open Label Squalamine Lactate Ophthalmic Solution for the Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
This was a prospective, single center, open label, randomized study evaluating the biological effect of squalamine lactate ophthalmic solution, 0.2% combined with intravitreous ranibizumab in patients with macular edema secondary to branch, hemi-central and central retinal vein occlusion (BRVO, HRVO, CRVO).
Read the detailed description
At baseline, all eyes underwent ETDRS visual acuity measurements at 4 meters, a complete ophthalmological evaluation, SD-OCT imaging of the macula, and fluorescein angiographic assessment of capillary perfusion in the macula and peripheral fundus. All eyes received an initial 10 week mandatory loading period of topical squalamine therapy.
All eyes received mandatory intravitreal injections of ranibizumab 0.5mg at the conclusions of weeks 2 and 6. At the conclusion of week 10, eyes were randomized in a 1:1 ratio to continue squalamine drops bid or discontinue squalamine drops in the study eye. All eyes were examined every 4 weeks through the week 38 endpoint and were eligible to receive additional as needed ranibizumab 0.5mg injections starting at the conclusion of week 10 and every 4 weeks thereafter through week 34 depending upon prespecified visual acuity and OCT retreatment criteria.
Any eye with a decrease of 5 or more ETDRS letters or increase in CST on OCT of 50uM or more from their best previous measurements automatically received an additional ranibizumab 0.5mg injection beginning at the conclusion of week 10.
Eyes randomized to continue squalamine drops did so through the week 38 endpoint. SD-OCT measurements of the macula were obtained at every study visit. Fluorescein angiograms were performed on the study eye at baseline, weeks 10 and 38.
Safety endpoints included all adverse events spontaneously reported, elicited or observed were documented by the investigators at any visit.
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Being tested
- ranibizumab, Squalamine Lactate Ophthalmic Solution, 0.2%
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
0.5 mg IVT ranibizumab
Squalamine Lactate Ophthalmic Solution, 0.2%Drug
Squalamine Lactate Ophthalmic Solution BID
| Study group | Role | What they receive |
|---|---|---|
| Squalamine and ranibizumab to Week 10 | Experimental | All eyes received an initial 10 week mandatory loading period of topical Squalamine Lactate Ophthalmic Solution, 0.2% therapy.
All eyes received mandatory intravitreal injections of ranibizumab 0.5mg at the conclusions of weeks 2 and 6.
Randomize at Week 10 to 2 different groups - Squalamine and No Squalamine, continue PRN ranibizumab in both groups Receives: Drug: ranibizumab; Drug: Squalamine Lactate Ophthalmic Solution, 0.2% |
| Continue Squalamine, ranibizumab PRN | Experimental | Continue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN Receives: Drug: ranibizumab |
| Stop Squalamine, ranibizumab PRN | Experimental | Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN Receives: Drug: ranibizumab; Drug: Squalamine Lactate Ophthalmic Solution, 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Function - Efficacy
Mean change in ETDRS letter score from baseline
Measured: Baseline to Week 38
Secondary outcomes (4)
Visual Function - Efficacy
Eyes with visual outcomes of 20/40 or better at Week 38 compared to Baseline Visit
Measured: Baseline to Week 38
Retinal Anatomy - Efficacy
Proportion of eyes with Central Subfield Thickness (CST) on SD-OCT less than 325 microns at Week 38
Measured: Baseline to Week 38
Safety and Tolerability as measured by adverse event reporting and ophthalmologic examination from Baseline to Week 38
Safety as measured by adverse event reporting and ophthalmologic examination from Baseline to Week 38
Measured: Baseline to Week 38
Concomitant ranibizumab administration - efficacy
Number of injections of 0.5 mg ranibizumab to keep edema resolved from Week 2 through Week 34 of study
Measured: Baseline to Week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohr Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cumberland Valley Retina Consultants, PC
- Responsible party
- Sponsor
- Investigators
- John Wroblewski, MD, Principal investigator, Cumberland Valley Retinal Consultants, Hagerstown, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614937
- Sponsor's protocol ID
- OHR-004
- Status last verified
- Nov 2015
- First submitted
- 23 Nov 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Squalamine Lactate Ophthalmic Solution for the Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
- ClinicalTrials.gov ID
- NCT02614937
- Acronym / sponsor ID
- OHR-004
- Conditions
- Retinal Vein Occlusion, Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ohr Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cumberland Valley Retina Consultants, PC
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Nov 2015 (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.
This was a prospective, single center, open label, randomized study evaluating the biological effect of squalamine lactate ophthalmic solution, 0.2% combined with intravitreous ranibizumab in patients with macular edema secondary to branch, hemi-central and central retinal vein occlusion (BRVO, HRVO, CRVO).
Detailed description
At baseline, all eyes underwent ETDRS visual acuity measurements at 4 meters, a complete ophthalmological evaluation, SD-OCT imaging of the macula, and fluorescein angiographic assessment of capillary perfusion in the macula and peripheral fundus. All eyes received an initial 10 week mandatory loading period of topical squalamine therapy.
All eyes received mandatory intravitreal injections of ranibizumab 0.5mg at the conclusions of weeks 2 and 6. At the conclusion of week 10, eyes were randomized in a 1:1 ratio to continue squalamine drops bid or discontinue squalamine drops in the study eye. All eyes were examined every 4 weeks through the week 38 endpoint and were eligible to receive additional as needed ranibizumab 0.5mg injections starting at the conclusion of week 10 and every 4 weeks thereafter through week 34 depending upon prespecified visual acuity and OCT retreatment criteria.
Any eye with a decrease of 5 or more ETDRS letters or increase in CST on OCT of 50uM or more from their best previous measurements automatically received an additional ranibizumab 0.5mg injection beginning at the conclusion of week 10.
Eyes randomized to continue squalamine drops did so through the week 38 endpoint. SD-OCT measurements of the macula were obtained at every study visit. Fluorescein angiograms were performed on the study eye at baseline, weeks 10 and 38.
Safety endpoints included all adverse events spontaneously reported, elicited or observed were documented by the investigators at any visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Squalamine and ranibizumab to Week 10 | Experimental | Drug: ranibizumab, Drug: Squalamine Lactate Ophthalmic Solution, 0.2%All eyes received an initial 10 week mandatory loading period of topical Squalamine Lactate Ophthalmic Solution, 0.2% therapy. All eyes received mandatory intravitreal injections of ranibizumab 0.5mg at the conclusions of weeks 2 and 6. Randomize at Week 10 to 2 different groups - Squalamine and No Squalamine, continue PRN ranibizumab in both groups |
| Continue Squalamine, ranibizumab PRN | Experimental | Drug: ranibizumabContinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN |
| Stop Squalamine, ranibizumab PRN | Experimental | Drug: ranibizumab, Drug: Squalamine Lactate Ophthalmic Solution, 0.2%Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eyes with treatment naïve, center involving macular edema secondary to BRVO, HRVO or CRVO in patients of at least 40 years of age
- Macular edema of 1-4 months duration prior to the baseline visit
- Best corrected baseline ETDRS visual acuity of 20/40 to 20/320 Snellen equivalent using the 4 meter testing method
- Baseline CST greater than or equal to 325uM using SD-OCT imaging
- Less than 50% foveal capillary ring disruption as defined by fluorescein angiography (FA)
Key exclusion criteria (9 listed)
- Eyes with ocular pathology other than RVO related macular edema such as clinically significant cataract or media opacity, diabetic retinopathy, macular degeneration, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or intraocular tumor
- Intraocular surgery within 6 months prior to baseline
- Two-plus or greater afferent pupillary defect (APD) in the study eye
- Likelihood of evidence driven indication for peripheral scatter photocoagulation within 6 months of recruitment
- History of previous intravitreal pharmacologic treatment of any kind in the study eye
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 |
|---|---|---|
| ranibizumabAlso: Lucentis0.5 mg IVT ranibizumab | Drug | Continue Squalamine, ranibizumab PRN, Squalamine and ranibizumab to Week 10, Stop Squalamine, ranibizumab PRN |
| Squalamine Lactate Ophthalmic Solution, 0.2%Squalamine Lactate Ophthalmic Solution BID | Drug | Squalamine and ranibizumab to Week 10, Stop Squalamine, ranibizumab PRN |
Primary outcome
Visual Function - Efficacy
Time frame: Baseline to Week 38
Mean change in ETDRS letter score from baseline
4 secondary outcomes
Visual Function - Efficacy
Time frame: Baseline to Week 38
Retinal Anatomy - Efficacy
Time frame: Baseline to Week 38
Safety and Tolerability as measured by adverse event reporting and ophthalmologic examination from Baseline to Week 38
Time frame: Baseline to Week 38
Concomitant ranibizumab administration - efficacy
Time frame: Baseline to Week 38
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 25 Nov 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.
John Wroblewski, MD principal investigator
Cumberland Valley Retinal Consultants, Hagerstown, MD
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ranibizumab and Squalamine Lactate Ophthalmic Solution, 0.2% in people with Retinal Vein Occlusion and Macular Edema, run by Ohr Pharmaceutical Inc..
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 7 inclusion and 9 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Visual Function - Efficacy (time frame: Baseline to Week 38). 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 25 Nov 2015.