CAPTAIN:CNV Assessment by Pattern Electroretinography - Full Text View

CAPTAIN:CNV Assessment by Pattern Electroretinography

This study is currently recruiting participants.
Verified by Washington University School of Medicine, October 2007

Sponsors and Collaborators:	Washington University School of Medicine Genentech
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00500344

Purpose

CNV from AMD is the leading cause of blindness in people over 50 in North America. The hypothesis is to determine if there is an improvement in retinal function determined by ERG following treatment with ranibizumab for AMD

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: Lucentis (ranibizumab)	Phase I

Genetics Home Reference related topics:

X-linked juvenile retinoschisis

MedlinePlus related topics:

Macular Degeneration

Drug Information available for:

Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	CAPTAIN: Choroidal Neovascularization Assessment by Pattern Electroretinography After Ranibizumab in Naive Age-Related Macular Degeneration Patients

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

To determine if there is an improvement in retinal function determined by the ERG following treatment with ranibizumab [ Time Frame: 6 months ]

Secondary Outcome Measures:

To determine if there is an improvement in visual acuity and retinal function as determined by ERG [ Time Frame: 6 months ]
Correlation between change in PERG and mean change in VA at 6 months [ Time Frame: 6 months ]
Mean change in VA from baseline to 0 months and 6 months [ Time Frame: 6 months ]

Estimated Enrollment:	20
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1	Drug: Lucentis (ranibizumab) intravitreal injection

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Eligibility

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

Criteria

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age ≥ 50 years
Treatment naive AMD patients that are determined to be candidates for ranibizumab
Visual acuity 20/40 to 20/320

Exclusion Criteria:

Pregnancy
Prior enrollment in the study
Previous therapy for AMD or other retinal diseases which may be used in the treatment of AMD
Any other condition that the investigator believes would pose a significant hazard to the subject if on-label ranibizumab were prescribed
Any condition that would interfere with the ERG recording (such as media opacities including lens or corneal opacity)
Concurrent eye disease in the study eye that could compromise visual acuity (such as diabetic retinopathy, advanced glaucoma)
Any condition causing the patient to have a significant tremor that would interfere with the patient's ability to remain still during the ERG (such as Parkinson's disease)
Participation in another simultaneous medical investigation or trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500344

Contacts


Contact: Rajendra S Apte, MD, PhD	314.747.5262	apte@vision.wustl.edu

Contact: Pam Light, CCRC	314.367.1278 ext 2287	bristudies@barnesretinainstute.com

Locations


United States, Missouri
	Barnes Retina Institute	Recruiting
	St. Louis, Missouri, United States, 63110
	Contact: Pam Light, CCRC 314-367-1278 ext 2287 bristudies@vision.wustl.edu
	Principal Investigator: Rajendra S. Apte, MD, PhD

Sponsors and Collaborators

Washington University School of Medicine

Genentech

Investigators


Principal Investigator:	Rajendra S. Apte, MD, PhD	Washington University School of Medicine

More Information

Publications:

Klein R, Peto T, Bird A, Vannewkirk MR. The epidemiology of age-related macular degeneration. Am J Ophthalmol. 2004 Mar;137(3):486-95. Review.

van Leeuwen R, Klaver CC, Vingerling JR, Hofman A, de Jong PT. Epidemiology of age-related maculopathy: a review. Eur J Epidemiol. 2003;18(9):845-54. Review.

Study ID Numbers:	FVF3799S
First Received:	July 10, 2007
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00500344
Health Authority:	United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:

Age-related Macular Degeneration

Choroidal neovascularization

Electroretinography

Retinal function

Study placed in the following topic categories:

Metaplasia

Eye Diseases

Choroid Diseases

Retinal Degeneration

Macular Degeneration

Neovascularization, Pathologic

Retinal Diseases

Retinal degeneration

Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases

Pathologic Processes

ClinicalTrials.gov processed this record on November 04, 2008