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rhuFab V2

Phase 3

Choroidal Neovascularization | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: May 16, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment5,000

FDA Designations

No designations recorded

Clinical trial landscape

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 an investigational drug being studied for the treatment of choroidal neovascularization, macular degeneration, and age-related maculopathy. It is administered via intravitreal injection and is being developed for ophthalmology indications.

Who makes rhuFab V2?

rhuFab V2 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug for the treatment of eye conditions such as age-related macular degeneration.

What phase is rhuFab V2 in?

rhuFab V2 is in Phase 1 clinical development. It has completed four clinical trials, including Phase 1 and Phase 3 studies, but it remains investigational and has not been approved by regulatory authorities.

What clinical trials is rhuFab V2 in?

rhuFab V2 has completed four clinical trials, including NCT00056823, a Phase 1 study combining the drug with Visudyne in age-related maculopathy; NCT00056836 and NCT00061594, both Phase 3 studies in macular degeneration; and NCT00251459, a Phase 3 study in choroidal neovascularization secondary to age-related macular degeneration.

Is rhuFab V2 the same as ranibizumab?

rhuFab V2 is also known as ranibizumab. One of its completed trials, NCT00251459, is titled 'A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD),' confirming the alternative name.