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Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion

Primary Purpose

Retinal Vein Occlusion, Macular Edema

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ranibizumab
Squalamine Lactate Ophthalmic Solution, 0.2%
Sponsored by
Ohr Pharmaceutical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Squalamine and ranibizumab to Week 10

    Continue Squalamine, ranibizumab PRN

    Stop Squalamine, ranibizumab PRN

    Arm Description

    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 use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN

    Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN

    Outcomes

    Primary Outcome Measures

    Visual Function - Efficacy
    Mean change in ETDRS letter score from baseline

    Secondary Outcome Measures

    Visual Function - Efficacy
    Eyes with visual outcomes of 20/40 or better at Week 38 compared to Baseline Visit
    Retinal Anatomy - Efficacy
    Proportion of eyes with Central Subfield Thickness (CST) on SD-OCT less than 325 microns at 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
    Concomitant ranibizumab administration - efficacy
    Number of injections of 0.5 mg ranibizumab to keep edema resolved from Week 2 through Week 34 of study

    Full Information

    First Posted
    November 23, 2015
    Last Updated
    November 24, 2015
    Sponsor
    Ohr Pharmaceutical Inc.
    Collaborators
    Cumberland Valley Retina Consultants, PC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02614937
    Brief Title
    Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ohr Pharmaceutical Inc.
    Collaborators
    Cumberland Valley Retina Consultants, PC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Vein Occlusion, Macular Edema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Squalamine and ranibizumab to Week 10
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Continue Squalamine, ranibizumab PRN
    Arm Type
    Experimental
    Arm Description
    Continue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
    Arm Title
    Stop Squalamine, ranibizumab PRN
    Arm Type
    Experimental
    Arm Description
    Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
    Intervention Type
    Drug
    Intervention Name(s)
    ranibizumab
    Other Intervention Name(s)
    Lucentis
    Intervention Description
    0.5 mg IVT ranibizumab
    Intervention Type
    Drug
    Intervention Name(s)
    Squalamine Lactate Ophthalmic Solution, 0.2%
    Intervention Description
    Squalamine Lactate Ophthalmic Solution BID
    Primary Outcome Measure Information:
    Title
    Visual Function - Efficacy
    Description
    Mean change in ETDRS letter score from baseline
    Time Frame
    Baseline to Week 38
    Secondary Outcome Measure Information:
    Title
    Visual Function - Efficacy
    Description
    Eyes with visual outcomes of 20/40 or better at Week 38 compared to Baseline Visit
    Time Frame
    Baseline to Week 38
    Title
    Retinal Anatomy - Efficacy
    Description
    Proportion of eyes with Central Subfield Thickness (CST) on SD-OCT less than 325 microns at Week 38
    Time Frame
    Baseline to Week 38
    Title
    Safety and Tolerability as measured by adverse event reporting and ophthalmologic examination from Baseline to Week 38
    Description
    Safety as measured by adverse event reporting and ophthalmologic examination from Baseline to Week 38
    Time Frame
    Baseline to Week 38
    Title
    Concomitant ranibizumab administration - efficacy
    Description
    Number of injections of 0.5 mg ranibizumab to keep edema resolved from Week 2 through Week 34 of study
    Time Frame
    Baseline to Week 38

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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 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%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Wroblewski, MD
    Organizational Affiliation
    Cumberland Valley Retinal Consultants, Hagerstown, MD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion

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