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rhuFab V2

Phase 3

Choroidal Neovascularization | Monoclonal antibody | Ophthalmology |Roche Holding AG|Trials Updated: May 16, 2014

rhuFab V2 target and mechanism

ModalityMonoclonal antibody

Also known as rhuFab V2 (ranibizumab)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials6
Total Enrollment6,594

FDA Designations

No designations recorded

rhuFab V2 clinical trials

rhuFab V2 · 6 trials · 4 indications

Phase 3 5Phase 1 1
NCT00251459A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)Choroidal Neovascularization
COMPLETED5,000 Analytics
NCT00090623A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)Macular Degeneration
COMPLETED180 Analytics
NCT00061594A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular DegenerationMacular Degeneration
COMPLETED426 Analytics
NCT00056836A Study to Evaluate rhuFab V2 in Subjects With Minimally Classic or Occult Subfoveal Neovascular Macular DegenerationMacular Degeneration
COMPLETED720 Analytics
NCT00095433Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)Macular Degeneration
COMPLETED100 Analytics
PHASE3COMPLETED
A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Choroidal NeovascularizationUnlock trial analytics
PHASE3COMPLETED
A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
Macular DegenerationUnlock trial analytics
PHASE3COMPLETED
A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration
Macular DegenerationUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate rhuFab V2 in Subjects With Minimally Classic or Occult Subfoveal Neovascular Macular Degeneration
Macular DegenerationUnlock trial analytics
PHASE3COMPLETED
Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Cohort 1: The primary safety outcome measure is the incidence of SAEs (ocular and non ocular) evaluated through Month 12.
Cohort 2: The primary safety outcome measure is the incidence of SAEs (ocular and non-ocular) and AEs (ocular and non-ocular) evaluated through Month 12.

Secondary Endpoints

Incidence of AEs (ocular and non-ocular) evaluated through Month 12
Proportion of subjects who lose at least 15 letters in BCVA at Month 12 compared with baseline
Mean time to retreatment following the initial three monthly loading doses
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Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
rhuFab V2 (ranibizumab)DRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed Informed Consent Form * Age ≥ 50 years * Subfoveal CNV secondary to AMD, with evidence of recent disease progression, as defined by any of the following (lesion is eligible if it meets any one of the following criteria): ≥ 5 letters (or ≥ 1 Snellen line) of BCVA lost wi...

Countries:United StatesAustraliaCzechiaFranceGermanyHungary
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Frequently asked questions about rhuFab V2

What is rhuFab V2 used for?

rhuFab V2 is used for age-related macular degeneration and the choroidal neovascularization that can accompany it, a condition also described as age-related maculopathy. It is an ophthalmology monoclonal antibody developed by Roche Holding AG. The clinical program enrolled adults aged 50 years and older with these neovascular eye conditions.

Who makes rhuFab V2?

rhuFab V2 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored the clinical trial program for the drug in neovascular age-related macular degeneration and related choroidal neovascularization.

What phase is rhuFab V2 in?

rhuFab V2 is in Phase 1 development and is investigational. Its registered trials were conducted as Phase 3 studies, and all four of those trials are now completed, with no active trials listed. The program enrolled approximately 5,000 participants across its studies.

What clinical trials is rhuFab V2 in?

Four completed trials are registered for rhuFab V2: NCT00251459, NCT00095433, NCT00090623, and NCT00061594. NCT00251459 was the largest, enrolling 5,000 participants with choroidal neovascularization secondary to age-related macular degeneration. NCT00061594 compared rhuFab V2 with verteporfin photodynamic therapy in subfoveal neovascular macular degeneration.

Is rhuFab V2 the same as ranibizumab?

Yes, rhuFab V2 is also known as ranibizumab. The two names refer to the same monoclonal antibody, and the registered trials use both names, including studies titled with rhuFab V2 and one titled with ranibizumab in choroidal neovascularization secondary to age-related macular degeneration.

How was rhuFab V2 studied in its clinical trials?

The rhuFab V2 trials were randomized and enrolled adults aged 50 years and older with macular degeneration or choroidal neovascularization. NCT00061594 was an active comparison against verteporfin photodynamic therapy, while the other registered studies were uncontrolled. The trials were conducted in the United States and several other countries, including Australia, Czechia, France, Germany, and Hungary.