Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial

University of Pennsylvania

Status and phase: Completed; Phase 3

Conditions: Age Related Macular Degeneration

Treatments: Drug: bevacizumab; Drug: ranibizumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00593450

NEI-137

U10EY017823 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.

A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.

Full description

Age related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. More than 1.6 million people in the US currently have one or both eyes affected by the advanced stage of AMD.

Lucentis® is the most effective treatment for neovascular AMD studied to date. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several investigators began evaluating intravitreal Avastin® for the treatment of CNV. Given its molecular similarity to Lucentis, its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative to Lucentis®.

In addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy.

Only a single eye in each patient was analyzed.

At the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.

Enrollment: 1,208 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active, subfoveal choroidal neovascularization (CNV)
• Fibrosis < 50% of total lesion area
• Visual acuity (VA) 20/25-20/320
• Age ≥ 50 yrs
• At least 1 drusen (>63μ) in either eye or late AMD in fellow eye

Exclusion criteria

• Previous treatment for CNV in study eye
• Other progressive retinal disease likely to compromise VA
• Contraindications to injections with Lucentis or Avastin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,208 participants in 4 patient groups

1

Active Comparator group

Description:

Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.

Treatment:

Drug: ranibizumab

2

Experimental group

Description:

Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.

Treatment:

Drug: bevacizumab

3

Experimental group

Description:

Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.

Treatment:

Drug: ranibizumab

4

Experimental group

Description:

Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.

Treatment:

Drug: bevacizumab