Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321997
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : May 4, 2006
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE May 2, 2006
First Posted Date  ICMJE May 4, 2006
Last Update Posted Date May 4, 2006
Study Start Date  ICMJE May 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.
Official Title  ICMJE A PHASE II/III RANDOMIZED, DOUBLE-MASKED, CONTROLLED, DOSE-RANGING, MULTI-CENTER COMPARATIVE TRIAL, IN PARALLEL GROUPS, TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREAL INJECTIONS OF EYE001 (ANTI-VEGF PEGYLATED APTAMER) GIVEN EVERY 6 WEEKS FOR 54 WEEKS, IN PATIENTS WITH EXUDATIVE AGE-RELATED MACULAR DEGENERATION (AMD)
Brief Summary The purpose of this study is to compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet AMD when compared to placebo injections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE Drug: Pegaptanib sodium
Study Arms  ICMJE Not Provided
Publications * Boyer DS, Goldbaum M, Leys AM, Starita C; V.I.S.I.O.N. Study Group. Effect of pegaptanib sodium 0.3 mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from V.I.S.I.O.N. study. Br J Ophthalmol. 2014 Nov;98(11):1543-6. doi: 10.1136/bjophthalmol-2013-304075. Epub 2014 Jul 4.

*   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 Completed
Enrollment  ICMJE
 (submitted: May 2, 2006)
540
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects of either gender, aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD. Best corrected visual acuity in the study eye between 20/40 and 20/320.

Exclusion Criteria:

Any prior subfoveal thermal laser therapy.

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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00321997
Other Study ID Numbers  ICMJE EOP1003 and EOP1004
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 May 2006

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