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bevasiranib

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment135
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00259753Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular DegenerationPHASE2 COMPLETED 120Jul 1, 2005Dec 1, 2007Aug 5, 200823 United States
NCT00722384Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5PHASE1 COMPLETED 15Aug 1, 2004Dec 1, 2007Jul 25, 20081 United States
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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.
12 week
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
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
1EXPERIMENTAL0.2 mg/eye
2EXPERIMENTAL1.5 mg/eye
3EXPERIMENTAL3.0 mg/eye
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 Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: 1. Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD. 2. Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye. 3. Patients must be age 50 or older...

Countries:United States
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