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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00090532




Registration number
NCT00090532
Ethics application status
Date submitted
26/08/2004
Date registered
31/08/2004
Date last updated
27/05/2011

Titles & IDs
Public title
A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
Scientific title
A Phase 1/2, Randomized, Masked, Single and Multiple-Dose, Sequential Dose-Escalation Study of the Safety an Efficacy of AG-013958 in Subjects With Subfoveal Choroidal Neovascularization Associated With Age-related Macular Degeneration
Secondary ID [1] 0 0
A4321001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AG-013,958

Treatment: Drugs: AG-013,958
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the ocular and systemic safety of the study drug
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To evaluate the visual acuity change after study treatment
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Male and/or female subjects >=55 years of age

- Subfoveal choroidal neovascularization complicating age-related macular degeneration

- Subjects who are informed of, and willing and able to comply with, the investigational
nature of the study and are able to provide written informed consent in accordance
with institutional and regulatory guidelines
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other serious ocular diseases or conditions, including diabetic retinopathy and
glaucoma, that are likely to compromise visual acuity within 1 year

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Sydney
Recruitment hospital [2] 0 0
Pfizer Investigational Site - East Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Iowa
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
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Oregon
Country [12] 0 0
United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
Country [17] 0 0
Netherlands
State/province [17] 0 0
Gld
Country [18] 0 0
Netherlands
State/province [18] 0 0
GR
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Netherlands
State/province [19] 0 0
NH
Country [20] 0 0
Netherlands
State/province [20] 0 0
ZH
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Scotland
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Bristol
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total
of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55
years of age with "wet" age-related macular degeneration.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00090532
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00090532