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

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

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

ChemIDplus related topics:

Bevacizumab Ranibizumab

U.S. FDA Resources

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)

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 ]

Estimated Enrollment:	1200
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)
Subretinal hemorrhage and 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

Contacts


Contact: Daniel F Martin, MD	(404) 778-4815	dan.martin@emory.edu

Contact: Maureen G Maguire, PhD	(215) 615-1501	maguirem@mail.med.upenn.edu

Show 55 Study Locations

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators


Study Chair:	Daniel F Martin, MD	Emory University

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

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

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

Keywords provided by National Eye Institute (NEI):

bevacizumab

ranibizumab

choroidal neovascularization

Study placed in the following topic categories:

Eye Diseases

Retinal Degeneration

Macular Degeneration

Bevacizumab

Neovascularization, Pathologic

Retinal Diseases

Retinal degeneration

Choroidal Neovascularization

Additional relevant MeSH terms:

Antineoplastic Agents

Therapeutic Uses

Growth Substances

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 08, 2008

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