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Age-Related Neovascular Macular DegenerationPhase 3VIBERANCT00559715

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

A Phase 3 study testing bevacizumab and ranibizumab in people with Age-Related Neovascular Macular Degeneration, run by Klinikum Bremen-Mitte, gGmbH at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
bevacizumab and ranibizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
1 siteGermany
Study dates
Aug 2008to Aug 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Bernd Muehlbauer, Professor MD contact

+49 (0) 421 497 5352

b.muehlbauer@pharmakologie-bremen.de

Germany1 site, 1 recruiting

  • Department of Pharmacology at Klinikum Bremen Mitte

    Bremen, 28177

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

    Recruiting

Other trials in Germany

About this study

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

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.

Keywords
bevacizumab, ranibizumab, macular degeneration, age-related, neovascular, intravitreal injection, vision loss, outpatient setting
Medical subject headings
Macular Degeneration, Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabDrug

    Also called Avastin®

    1.25 mg intravitreally monthly/on demand

  • ranibizumabDrug

    Also called Lucentis®

    0.5 mg intravitreally monthly/on demand

Study groups in NCT00559715
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: bevacizumab
BActive comparatorNot described
Receives: Drug: ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with a loss of fewer than 15 letters at month 12

    Measured: 1 year

Secondary outcomes (9)

  1. Proportion of patients with a loss of fewer than 15 letters at month 24

    Measured: 2 years

  2. Mean change from baseline in BCVA at month 12 (IA) and month 24

    Measured: 2 years

  3. Proportion of patients with a treatment-free interval of at least 3 months' duration at any time point following month 2

    Measured: 2 years

  4. Number of doses of the study drugs

    Measured: 2 years

  5. Drop out rates

    Measured: 2 years

  6. Rate of non-responders

    Measured: 2 years

  7. Retinal lesions

    Measured: 2 years

  8. Adverse Events

    Measured: 2 years

  9. Quality of Life

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2007 (estimated)
  2. Study startAug 2008
  3. Primary completionAug 2009 (estimated)
  4. Study completionAug 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
366 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00559715
Sponsor's protocol ID
VIBERA_2007-004721-23
Acronym
VIBERA
Status last verified
Mar 2009
First submitted
15 Nov 2007
Last updated
26 Mar 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab and ranibizumab in people with Age-Related Neovascular Macular Degeneration, run by Klinikum Bremen-Mitte, gGmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bernd Muehlbauer, Professor MD (+49 (0) 421 497 5352, b.muehlbauer@pharmakologie-bremen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with a loss of fewer than 15 letters at month 12 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00559715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2009.

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