Recent Updates
Recently added Catalysts

AGN211745

Phase 1

Age-Related Macular Degeneration | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Aug 18, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLED
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00363714A Dose Escalation Trial of an Intravitreal Injection of Sirna-027 in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)PHASE1 COMPLETED 26Nov 1, 2004Apr 1, 2007Aug 18, 20082 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Adverse Events
Time frame 3 months: Baseline/Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84
Secondary Endpoints
Visual Acuity using the Diabetic Retinopathy Study chart
Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
IOP
Time frame 24 months: Screening, Day 1, Day 2, Day 7, Day 14, Day 28, Day 56, Day 84, Month 6, Month 9, Month 12, Month 18, Month 24
OCT
Time frame 3 months: Screening, Day 7, Day 14, Day 28, Day 56, Day 84
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALSingle intravitreal injection
2EXPERIMENTALSingle intravitreal injection
3EXPERIMENTALSingle intravitreal injection
4EXPERIMENTALSingle intravitreal injection
5EXPERIMENTALSingle intravitreal injection
6EXPERIMENTALSingle intravitreal injection
Interventions
NameTypeDescription
AGN211745DRUG100microgram single intravitreal injection
Unlock Study Design Details
Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Active AMD with Subfoveal CNV (classic and/or occult CNV) * CNV lesion thickness \>/= 250um by OCT assessment * Visual acuity in study eye of \</= 20/100 but not worse than 20/800 * Not eligible for or refused standard treatment Exclusion Criteria: * Females of childbearing ...

Countries:United States
Unlock Eligibility Criteria