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bevasiranib

Phase 3

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

bevasiranib development status

Highest phase Phase 3 (NCT00557791)
Phase scored for OPKPhase 2
Registered trials 5 across 1 sponsor since Dec 2005

bevasiranib target and mechanism

Molecular targetTLR3, VEGFA
Target classActivator
ModalitySmall molecule

Also known as Cand5

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials3
Total Enrollment183

FDA Designations

No designations recorded

bevasiranib clinical trials

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 EdemaUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration
Macular DegenerationUnlock trial analytics

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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Frequently asked questions about bevasiranib

What is bevasiranib used for?

Bevasiranib is an investigational ophthalmology drug studied for diabetic macular edema and macular degeneration, including wet age-related macular degeneration. It was developed by Opko Health Inc. and has been evaluated in Phase 2 clinical trials. It is not described as approved, so it remains an investigational candidate rather than an established therapy.

What does bevasiranib target?

Bevasiranib targets TLR3 and VEGFA. It is classified as an activator within its target class, and it is a small molecule modality. Targeting VEGFA relates to vascular signaling in the eye, while TLR3 is an immune-related receptor. These targets were the basis for its study in retinal conditions involving abnormal blood vessel activity.

Who makes bevasiranib?

Bevasiranib is developed by Opko Health Inc., which trades under the ticker OPK. The company sponsored the clinical studies of the drug in ophthalmology indications. Opko Health is the developer associated with bevasiranib across its macular degeneration and diabetic macular edema programs.

What phase is bevasiranib in?

Bevasiranib is in Phase 2 development. It is an investigational drug and is not described as FDA approved. Its clinical program includes completed Phase 1 and Phase 2 studies, with no active trials currently listed. The completed trials enrolled a total of 135 participants across the studied indications.

What clinical trials is bevasiranib in?

Bevasiranib has been studied in completed trials including NCT00722384, an open-label Phase 1 tolerability study of five dose levels in macular degeneration, and NCT00306904, a Phase 2 safety and efficacy study in diabetic macular edema. A third completed Phase 2 trial, NCT00259753, evaluated it in wet age-related macular degeneration.

Is bevasiranib the same as Cand5?

Yes, bevasiranib is also known as Cand5. The name Cand5 appears in the titles of its clinical trials, including the Phase 2 studies in diabetic macular edema and wet age-related macular degeneration. Readers searching for Cand5 are looking at the same investigational ophthalmology drug developed by Opko Health Inc.