Phase 3
Completed N=1,185
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Source: ClinicalTrials.gov NCT00593450 ↗Enrolled (actual)
1,185
Serious AEs
21.5%
Results posted
Aug 2012
Primary outcomePrimary: Change From Baseline in Visual-acuity Score (Continuous) — 8.5; 8.0; 6.8; 5.9 No. of Letters — p=0.16
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual-acuity Score (Continuous) |
8.5; 8.0; 6.8; 5.9 | 0.16 |
| SECONDARY Change From Baseline Visual-acuity Score (Frequency) |
97; 83; 71; 76; 90; 98 | — |
| SECONDARY Visual-acuity Score and Snellen Equivalent (Frequency) |
42; 45; 38; 40; 149; 134 | — |
| SECONDARY Visual-acuity Score and Snellen Equivalent (Continuous) |
68.8; 68.4; 68.4; 66.5 | — |
| SECONDARY Number of Treatments |
11.7; 11.9; 6.9; 7.7 | — |
| SECONDARY Average Cost of Drug/Patient |
23400; 595; 13800; 385 | — |
| SECONDARY Total Thickness at Fovea |
266; 300; 294; 308 | — |
| SECONDARY Total Thickness Change From Baseline at Fovea |
-196; -164; -168; -152 | — |
| SECONDARY Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea |
152; 172; 166; 172 | — |
| SECONDARY Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea |
-100; -79; -81; -79 | — |
| SECONDARY Fluid on Optical Coherence Tomography |
124; 69; 68; 52; 151; 188 | — |
| SECONDARY Dye Leakage on Angiogram |
167; 153; 133; 111; 97; 100 | — |
| SECONDARY Area of Lesion |
6.6; 6.5; 7.3; 7.0 | — |
| SECONDARY Area of Lesion Change From Baseline |
-0.1; 0.3; 0.6; 1.3 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline |
-2.1; -5.4; -5.2; -4.5 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline |
-0.9; -1.4; -1.9; -2.1 | — |
Eligibility Criteria
Inclusion Criteria
- Active, subfoveal choroidal neovascularization (CNV)
- Fibrosis 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
Data sourced from ClinicalTrials.gov (NCT00593450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.