A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

NCT00354445

Last updated date
Study Location
Retina Research Institute of Texas, LLC
Abilene, Texas, 79606, United States
Contact
1-866-622-8436

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age-Related Macular Degeneration (AMD)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subfoveal CNV secondary to AMD

- At least 1 but not more than 3 prior treatments for AMD

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subfoveal scar or subfoveal atrophy


- Significant media opacities, including cataract, which might interfere with visual
acuity

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Age-Related Macular Degeneration (AMD)A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
NCT00354445
  1. Abilene, Texas
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
Official Title  ICMJE A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement
Brief Summary The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration (AMD)
Intervention  ICMJE Drug: pegaptanib sodium (Macugen)
Study Arms  ICMJE Not Provided
Publications * Friberg TR, Tolentino M; LEVEL Study Group, Weber P, Patel S, Campbell S, Goldbaum M. Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study. Br J Ophthalmol. 2010 Dec;94(12):1611-7. doi: 10.1136/bjo.2009.174946. Epub 2010 May 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: July 18, 2006)
1000
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subfoveal CNV secondary to AMD
  • At least 1 but not more than 3 prior treatments for AMD

Exclusion Criteria:

  • Subfoveal scar or subfoveal atrophy
  • Significant media opacities, including cataract, which might interfere with visual acuity
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00354445
Other Study ID Numbers  ICMJE EOP1023
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eyetech Pharmaceuticals
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Eyetech Pharmaceuticals
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP