Prevention of Vision Loss in Patients With Age-Related Macular Degeneration (AMD) by Intravitreal Injection of Bevacizumab and Ranibizumab (VIBERA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Klinikum Bremen-Mitte, gGmbH.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kompetenzzentrum für Klinische Studien, Bremen
Information provided by:
Klinikum Bremen-Mitte, gGmbH
ClinicalTrials.gov Identifier:
NCT00559715
First received: November 15, 2007
Last updated: March 25, 2009
Last verified: March 2009
  Purpose

The study is designed to demonstrate the therapeutic non-inferiority of the recombinant humanized monoclonal VEGF antibody bevacizumab administered by intravitreal injection in the treatment of AMD in comparison to the related fragment ranibizumab.


Condition Intervention Phase
Age-Related Neovascular Macular Degeneration
Drug: bevacizumab
Drug: ranibizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prevention of Vision Loss in Patients With Age-Related Neovascular Macular Degeneration by Intravitreal Injection of Bevacizumab and Ranibizumab in a Typical Outpatient Setting

Resource links provided by NLM:


Further study details as provided by Klinikum Bremen-Mitte, gGmbH:

Primary Outcome Measures:
  • Proportion of patients with a loss of fewer than 15 letters at month 12 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with a loss of fewer than 15 letters at month 24 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Mean change from baseline in BCVA at month 12 (IA) and month 24 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients with a treatment-free interval of at least 3 months' duration at any time point following month 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of doses of the study drugs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Drop out rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rate of non-responders [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Retinal lesions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 366
Study Start Date: August 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab
1.25 mg intravitreally monthly/on demand
Other Name: Avastin®
Active Comparator: B Drug: ranibizumab
0.5 mg intravitreally monthly/on demand
Other Name: Lucentis®

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with visual impairment (best corrected visual acuity of 20/40 to 20/320 (Snellen equivalent, ETDRS chart)) due to an active primary or recurrent CNV associated with age-related macular degeneration involving the foveal center, presenting with either:

    • a classical / predominantly classical lesion with largest diameter of SNVM smaller than greatest distance between major temporal vascular arcades or
    • a minimally classical lesion or an occult lesion with no classic choroidal neovascularization

Exclusion Criteria:

  • Known or suspected hypersensitivity to ranibizumab or bevacizumab
  • Participation in any clinical trial within the last 4 weeks
  • Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, bevacizumab ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
  • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Previous laser photocoagulation (juxtafoveal or extrafoveal) in the study eye
  • History of vitreoretinal surgery in the study eye
  • History of submacular surgery or other surgical intervention for AMD in the study eye
  • Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size
  • Subfoveal fibrosis or atrophy in the study eye
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Retinal pigment epithelial tear involving the macula in the study eye
  • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either:
  • require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or
  • if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 24-month study period
  • Active intraocular, ocular, or periocular inflammation (any grade "trace" or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Aphakia or absence of the posterior capsule in the study eye
  • Spherical equivalent of the refractive error in the study eye demonstrating more than −8 diopters of myopia
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding day 0
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure [IOP] of 30 mmHg or more despite treatment with antiglaucoma medications)
  • History of glaucoma filtering surgery in the study eye
  • History of corneal transplant in the study eye
  • Premenopausal women not using adequate contraception
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
  • Current treatment for active systemic infection
  • History of allergy to fluorescein, not amenable to treatment with diphenhydramine
  • Inability to obtain fundus photographs or FA of sufficient quality to be analyzed and graded by the blinded evaluation center
  • Inability to comply with study or follow-up procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559715

Contacts
Contact: Bernd Muehlbauer, Professor MD +49 (0) 421 497 5352 b.muehlbauer@pharmakologie-bremen.de

Locations
Germany
Department of Pharmacology at Klinikum Bremen Mitte Recruiting
Bremen, Germany, 28177
Contact: Bernd Muehlbauer, Professor MD    +49 (0) 421 497 5352    b.muehlbauer@pharmakologie-bremen.de   
Sponsors and Collaborators
Klinikum Bremen-Mitte, gGmbH
Kompetenzzentrum für Klinische Studien, Bremen
Investigators
Principal Investigator: Bernd Muehlbauer, Professor MD Department of Pharmacology, Klinikum Bremen Mitte, Bremen, Germany
  More Information

No publications provided

Responsible Party: Bernd Muehlbauer, Professor MD, Klinikum Bremen Mitte gGmbH
ClinicalTrials.gov Identifier: NCT00559715     History of Changes
Other Study ID Numbers: VIBERA_2007-004721-23
Study First Received: November 15, 2007
Last Updated: March 25, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum Bremen-Mitte, gGmbH:
bevacizumab
ranibizumab
macular degeneration
age-related
neovascular
intravitreal injection
vision loss
outpatient setting

Additional relevant MeSH terms:
Blindness
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014