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bevasiranib

Phase 2

Diabetic Macular Edema | Small molecule | Ophthalmology |Opko Health Inc.|Last Updated: Aug 5, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

bevasiranib · 3 trials · 2 indications

Phase 2 2Phase 1 1
NCT00306904Safety and Efficacy Study of Small Interfering RNA Molecule (Cand5) to Treat Diabetic Macular EdemaDiabetic Macular Edema
COMPLETED48 Analytics
NCT00259753Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular DegenerationMacular Degeneration
COMPLETED120 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Small Interfering RNA Molecule (Cand5) to Treat Diabetic Macular Edema
Diabetic Macular Edema
NCT0030690448
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PHASE2COMPLETED
Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
Macular Degeneration
NCT00259753120
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Study Endpoints

Primary Endpoints

Change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
Complications, including those related to the intravitreal injection, and adverse events, and loss of lines of best-corrected visual acuity, slit lamp findings, lens opacification, intraocular pressure, fundus findings, and laboratory findings.

Secondary Endpoints

Mean BCVA line/letters change from baseline at the 12-week evaluation.
The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.
12 week
Stabilization of visual acuity (prevention of loss of three or more lines on the ETDRS chart), stabilization of lesion size, lack of leakage of lesion, or decrease in subretinal fluid
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL3.0 mg/eye dose group
2EXPERIMENTAL1.5 mg/eye dose group
3EXPERIMENTAL0.2 mg/eye dose group
4EXPERIMENTAL1.5 mg bevasiranib in the study eye
5EXPERIMENTAL3.0 mg bevasiranib in the study eye.

Interventions

NameTypeDescription
bevasiranibDRUG -
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients must be male or female age 21 or older. 2. Patient must sign (and be given) a copy of the written informed consent form. 3. Patients must have the diagnosis of diabetes mellitus (type 1 or type 2). Patients with the following will be considered to be sufficient evide...

Countries:United States
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Competitive Landscape -Diabetic Macular Edema 15 trials

CompanyTickerTrialsLead PhaseDrugs
EyePoint, Inc.EYPT2PHASE3EYP-1901, Aflibercept
Regeneron Pharmaceuticals, Inc.REGN1PHASE3Aflibercept
Oculis Holding AGOCS2PHASE3Dexamethasone, Vehicle
AbbVie, Inc.ABBV3PHASE2ABBV-RGX-314 Dose 1, Steroid, Aflibercept
Outlook Therapeutics, Inc.OTLK1PHASE3bevacizumab
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-150 IVT, Aflibercept IVT
AlvotechALVO1PHASE3AVT29, Eylea HD
Kiora Pharmaceuticals, Inc.KPRX1PHASE2KIO-104
REGENXBIO, Inc.RGNX1PHASE2RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept
Ocugen IncOCGN1PHASE1OCU200
Adverum Biotechnologies, Inc.ADVM1 - ADVM-022
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Frequently asked questions about bevasiranib

What is bevasiranib used for?

Bevasiranib is an investigational small molecule being studied for the treatment of macular degeneration and diabetic macular edema. It has been evaluated in clinical trials for these ophthalmologic conditions, specifically for wet age-related macular degeneration and diabetic macular edema.

Who makes bevasiranib?

Bevasiranib is being developed by Opko Health Inc., a biopharmaceutical company traded on the NYSE under the ticker symbol OPK. The company has conducted clinical trials to evaluate the safety and efficacy of this investigational drug for ophthalmologic indications.

What phase is bevasiranib in?

Bevasiranib has completed Phase 2 clinical trials for macular degeneration and diabetic macular edema. It remains an investigational drug, as it has not been approved by regulatory authorities. The completed trials include two Phase 2 studies and one Phase 1 study.

What clinical trials is bevasiranib in?

Bevasiranib has been studied in two completed Phase 2 trials: NCT00259753 for wet age-related macular degeneration with 120 participants, and NCT00306904 for diabetic macular edema with 48 participants. A Phase 1 trial, NCT00722384, evaluated tolerability in 15 participants with macular degeneration.

Is bevasiranib the same as Cand5?

Yes, bevasiranib is also known as Cand5. Clinical trial records refer to the drug as Cand5, including studies NCT00259753 and NCT00306904, which evaluated the safety and efficacy of the small interfering RNA molecule Cand5 for eye conditions.

How does bevasiranib work?

Bevasiranib is a small interfering RNA molecule designed to target and silence specific genes involved in disease pathways. In the context of macular degeneration and diabetic macular edema, it is intended to interfere with the production of proteins that contribute to abnormal blood vessel growth in the eye.