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

Conditions

• Age Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ranibizumab — DRUG
  • 0.5 mg (0.05 mL)intravitreal injection
• bevacizumab — DRUG
  • 1.25 mg (0.05 mL)intravitreal injection

Study Details

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.

Key Dates

First listed

Jan 15, 2008

Start date

Feb 29, 2008

Status verified

Jul 2017

Primary completion

Dec 31, 2010

Completion

Apr 30, 2015

Study Design

Enrollment

1,208 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1
  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.
• Experimental: 2
  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.
• Experimental: 3
  Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
• Experimental: 4
  Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.

Primary Outcome Measure

Change From Baseline in Visual-acuity Score (Continuous) [ Time Frame: Baseline and 1 Year ]

Locations (59)

Find similar trials in Mesa, AZ

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