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

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ClinicalTrials.gov Identifier: NCT02614937
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Collaborator:
Cumberland Valley Retina Consultants, PC
Information provided by (Responsible Party):
Ohr Pharmaceutical Inc.

Tracking Information
First Submitted Date  ICMJE November 23, 2015
First Posted Date  ICMJE November 25, 2015
Last Update Posted Date November 25, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
Visual Function - Efficacy [ Time Frame: Baseline to Week 38 ]
Mean change in ETDRS letter score from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
  • Visual Function - Efficacy [ Time Frame: Baseline to Week 38 ]
    Eyes with visual outcomes of 20/40 or better at Week 38 compared to Baseline Visit
  • Retinal Anatomy - Efficacy [ Time Frame: Baseline to Week 38 ]
    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 [ Time Frame: Baseline to Week 38 ]
    Safety as measured by adverse event reporting and ophthalmologic examination from Baseline to Week 38
  • Concomitant ranibizumab administration - efficacy [ Time Frame: Baseline to Week 38 ]
    Number of injections of 0.5 mg ranibizumab to keep edema resolved from Week 2 through Week 34 of study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Retinal Vein Occlusion
  • Macular Edema
Intervention  ICMJE
  • Drug: ranibizumab
    0.5 mg IVT ranibizumab
    Other Name: Lucentis
  • Drug: Squalamine Lactate Ophthalmic Solution, 0.2%
    Squalamine Lactate Ophthalmic Solution BID
Study Arms  ICMJE
  • Experimental: Squalamine and ranibizumab to Week 10

    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

    Interventions:
    • Drug: ranibizumab
    • Drug: Squalamine Lactate Ophthalmic Solution, 0.2%
  • Experimental: Continue Squalamine, ranibizumab PRN
    Continue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
    Intervention: Drug: ranibizumab
  • Experimental: Stop Squalamine, ranibizumab PRN
    Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
    Interventions:
    • Drug: ranibizumab
    • Drug: Squalamine Lactate Ophthalmic Solution, 0.2%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2015)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02614937
Other Study ID Numbers  ICMJE OHR-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ohr Pharmaceutical Inc.
Study Sponsor  ICMJE Ohr Pharmaceutical Inc.
Collaborators  ICMJE Cumberland Valley Retina Consultants, PC
Investigators  ICMJE
Principal Investigator: John Wroblewski, MD Cumberland Valley Retinal Consultants, Hagerstown, MD
PRS Account Ohr Pharmaceutical Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP