Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Age Related Macular Degeneration |
Drug: ranibizumab Drug: bevacizumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT) |
- Change From Baseline in Visual-acuity Score (Continuous) [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline.
In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.
- Change From Baseline Visual-acuity Score (Frequency) [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
- Visual-acuity Score and Snellen Equivalent (Frequency) [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
- Visual-acuity Score and Snellen Equivalent (Continuous) [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly.
In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity.
- Number of Treatments [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Cumulative over the 1 year of trial
- Average Cost of Drug/Patient [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
- Total Thickness at Fovea [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
- Total Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
- Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
- Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
- Fluid on Optical Coherence Tomography [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
- Dye Leakage on Angiogram [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
- Area of Lesion [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
- Area of Lesion Change From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
- Change in Systolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
- Change in Diastolic Blood Pressure From Baseline [ Time Frame: Baseline and 1 Year ] [ Designated as safety issue: No ]
| Enrollment: | 1208 |
| Study Start Date: | February 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: ranibizumab
• 0.5 mg (0.05 mL)intravitreal injection
Other Name: Lucentis
|
|
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.
|
Drug: bevacizumab
• 1.25 mg (0.05 mL)intravitreal injection
Other Name: Avastin
|
|
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.
|
Drug: ranibizumab
• 0.5 mg (0.05 mL)intravitreal injection
Other Name: Lucentis
|
|
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.
|
Drug: bevacizumab
• 1.25 mg (0.05 mL)intravitreal injection
Other Name: Avastin
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 59 Study Locations| Study Chair: | Daniel F Martin, MD | The Cleveland Clinic |
| Study Chair: | Stuart L Fine, MD | Study Vice-Chair, University of Pennsylvania |
| Study Director: | Maureen G Maguire, PhD | Director of Coordinating Center, University of Pennsylvania |
| Study Director: | Glenn Jaffe,, MD | Director of OCT Reading Center, Duke University |
| Principal Investigator: | Juan E Grunwald, MD | Principal Investigator of Photography Reading Center, Universisty of Pennsylvania |
More Information
Additional Information:
Publications:
| Responsible Party: | Maureen Maguire, Carolyn F. Jones Professor of Ophthalmology, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00593450 History of Changes |
| Other Study ID Numbers: | NEI-137, U10EY017823 |
| Study First Received: | January 3, 2008 |
| Results First Received: | June 18, 2012 |
| Last Updated: | August 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pennsylvania:
|
bevacizumab ranibizumab choroidal neovascularization |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Bevacizumab Retinal Diseases Eye Diseases Angiogenesis Inhibitors Angiogenesis Modulating Agents |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013