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

NCT00559715 | Unknown Phase 3 DMC

• 1 other identifier: VIBERA_2007-004721-23
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age-Related Neovascular Macular Degeneration

Keywords

bevacizumab; ranibizumab; macular degeneration; age-related; neovascular; intravitreal injection; vision loss; outpatient setting

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (9)

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

  2 years

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

  2 years

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

  2 years

• Number of doses of the study drugs

  2 years

• Drop out rates

  2 years

Study Arms (2)

A

EXPERIMENTAL

Drug: bevacizumab

B

ACTIVE COMPARATOR

Drug: ranibizumab

Interventions

bevacizumab DRUG

1.25 mg intravitreally monthly/on demand

Also known as: Avastin®

A

ranibizumab DRUG

0.5 mg intravitreally monthly/on demand

Also known as: Lucentis®

B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Bremen-Mitte, gGmbH: lead
• Kompetenzzentrum für Klinische Studien, Bremen: collaborator

Study Sites (1)

Department of Pharmacology at Klinikum Bremen Mitte

Bremen, 28177, Germany

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Vision Disorders

Interventions

Bevacizumab; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bernd Muehlbauer, Professor MD

  Department of Pharmacology, Klinikum Bremen Mitte, Bremen, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernd Muehlbauer, Professor MD

CONTACT

+49 (0) 421 497 5352; b.muehlbauer@pharmakologie-bremen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2010
• Last Updated: March 26, 2009

Record last verified: 2009-03

Locations

DE (1)