A Phase 1/2 interventional study of ranibizumab and Squalamine Lactate Ophthalmic Solution, 0.2% in Retinal Vein Occlusion and Macular Edema, sponsored by Ohr Pharmaceutical Inc.. Completed. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2015-11-25.
Sponsored by Ohr Pharmaceutical Inc. · Phase 1/2, Interventional, and Treatment
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).
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Ohr Pharmaceutical Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
Drug: ranibizumab
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%
0.5 mg IVT ranibizumab
Also known as: Lucentis
Squalamine Lactate Ophthalmic Solution BID
Visual Function - Efficacy
Mean change in ETDRS letter score from baseline
Time frame: Baseline to Week 38
Visual Function - Efficacy
Eyes with visual outcomes of 20/40 or better at Week 38 compared to Baseline Visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 38
No study locations are listed for this record.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Ohr Pharmaceutical Inc.