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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.

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).

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Macular Edema Drug: ranibizumab Drug: Squalamine Lactate Ophthalmic Solution, 0.2% Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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

Drug: ranibizumab
0.5 mg IVT ranibizumab
Other Name: Lucentis

Drug: Squalamine Lactate Ophthalmic Solution, 0.2%
Squalamine Lactate Ophthalmic Solution BID

Experimental: Continue Squalamine, ranibizumab PRN
Continue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
Drug: ranibizumab
0.5 mg IVT ranibizumab
Other Name: Lucentis

Experimental: Stop Squalamine, ranibizumab PRN
Discontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
Drug: ranibizumab
0.5 mg IVT ranibizumab
Other Name: Lucentis

Drug: Squalamine Lactate Ophthalmic Solution, 0.2%
Squalamine Lactate Ophthalmic Solution BID




Primary Outcome Measures :
  1. Visual Function - Efficacy [ Time Frame: Baseline to Week 38 ]
    Mean change in ETDRS letter score from baseline


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614937


Sponsors and Collaborators
Ohr Pharmaceutical Inc.
Cumberland Valley Retina Consultants, PC
Investigators
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Principal Investigator: John Wroblewski, MD Cumberland Valley Retinal Consultants, Hagerstown, MD

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Responsible Party: Ohr Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT02614937     History of Changes
Other Study ID Numbers: OHR-004
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions
Ranibizumab
Squalamine
Ophthalmic Solutions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anticarcinogenic Agents
Protective Agents