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ranibizumab

Phase 1

Retinal Vein Occlusion | Small molecule | Ophthalmology |Cumberland Pharmaceuticals Inc.|Last Updated: Nov 25, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

ranibizumab · 1 trial · 2 indications

Phase 1 1
NCT02614937Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein OcclusionRetinal Vein Occlusion
COMPLETED20 Analytics
PHASE1COMPLETED
Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion
Retinal Vein OcclusionUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual Function - Efficacy
Baseline to Week 38

Mean change in ETDRS letter score from baseline

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Squalamine and ranibizumab to Week 10EXPERIMENTALAll 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 Squalamine, ranibizumab PRNEXPERIMENTALContinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN
Stop Squalamine, ranibizumab PRNEXPERIMENTALDiscontinue use of Squalamine Lactate Ophthalmic Solution, 0.2% after Week 10; continue ranibizumab 0.5 mg IVT PRN

Interventions

NameTypeDescription
ranibizumabDRUG0.5 mg IVT ranibizumab
Squalamine Lactate Ophthalmic Solution, 0.2%DRUGSqualamine Lactate Ophthalmic Solution BID
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo

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 equival...

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Frequently asked questions about ranibizumab

What is ranibizumab used for in Retinal Vein Occlusion?

Ranibizumab is a small molecule being studied for the treatment of Retinal Vein Occlusion, specifically for macular edema related to this condition. It is currently in Phase 1 clinical development and is not yet approved for this use.

Who makes ranibizumab?

Ranibizumab is being developed by Cumberland Pharmaceuticals Inc., a company traded on the NASDAQ under the ticker symbol CPIX. The drug is currently in Phase 1 clinical trials for Retinal Vein Occlusion.

What phase is ranibizumab in?

Ranibizumab is in Phase 1 clinical development for Retinal Vein Occlusion. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is ranibizumab in?

Ranibizumab has one completed clinical trial, NCT02614937, titled 'Study of Squalamine Lactate for the Treatment of Macular Edema Related to Retinal Vein Occlusion'. This Phase 1 trial enrolled 20 participants with Retinal Vein Occlusion and Macular Edema.

Is ranibizumab the same as squalamine lactate?

Ranibizumab is the drug name used in the context of this development program, and the clinical trial NCT02614937 refers to the study of Squalamine Lactate. The trial is investigating ranibizumab for macular edema related to Retinal Vein Occlusion.