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

NCT02614937 | Completed Phase 1

• 1 other identifier: OHR-004
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Retinal Vein Occlusion; Macular Edema

Outcome Measures

Primary Outcomes (1)

• Visual Function - Efficacy

  Mean change in ETDRS letter score from baseline

  Baseline to Week 38

Secondary Outcomes (4)

• Visual Function - Efficacy

  Baseline to Week 38

• Retinal Anatomy - Efficacy

  Baseline to Week 38

• Safety and Tolerability as measured by adverse event reporting and ophthalmologic examination from Baseline to Week 38

  Baseline to Week 38

• Concomitant ranibizumab administration - efficacy

  Baseline to Week 38

Study Arms (3)

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

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

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

Drug: ranibizumab; Drug: Squalamine Lactate Ophthalmic Solution, 0.2%

Interventions

ranibizumab DRUG

0.5 mg IVT ranibizumab

Also known as: Lucentis

Continue Squalamine, ranibizumab PRN; Squalamine and ranibizumab to Week 10; Stop Squalamine, ranibizumab PRN

Squalamine Lactate Ophthalmic Solution, 0.2% DRUG

Squalamine Lactate Ophthalmic Solution BID

Squalamine and ranibizumab to Week 10; Stop Squalamine, ranibizumab PRN

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Ohr Pharmaceutical Inc.: lead
• Cumberland Valley Retina Consultants, PC: collaborator

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John Wroblewski, MD

  Cumberland Valley Retinal Consultants, Hagerstown, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 25, 2015

Record last verified: 2015-11