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

Sponsor:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00593450

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab Ranibizumab

U.S. FDA Resources

Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:

Mean change in VA [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of treatments [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
3-line change in VA (15 letters on ETDRS chart) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Change in subretinal and intraretinal fluid on optical coherent tomography [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Change in lesion size on fluorescein angiography [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Incidence of endophthalmitis, retinal detachment, cataract, uveitis [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
Incidence of adverse events [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]
Cost [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Enrollment:	1208
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Experimental 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
3: Experimental 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
4: Experimental 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

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593450

Show 59 Study Locations

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators

Study Chair:	Daniel F Martin, MD	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:

Click here for more information about this study: Comparison of AMD Treatments Trials (CATT) This link exits the ClinicalTrials.gov site

NEI Clinical Studies Database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	National Eye Institute ( Maryann Redford, DDS,Group Leader, Collaborative Clinical Research )
Study ID Numbers:	NEI-137, U10 EY017823
Study First Received:	January 3, 2008
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00593450 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Eye Institute (NEI):

bevacizumab
ranibizumab
choroidal neovascularization

Additional relevant MeSH terms:

Bevacizumab
Antineoplastic Agents
Eye Diseases
Growth Substances
Physiological Effects of Drugs
Macular Degeneration
Retinal Degeneration

Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010