Back to resultsA Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pegaptanib sodium
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, pegaptanib sodium
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00321997
First Posted
May 2, 2006
Last Updated
May 2, 2006
Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00321997
Brief Title
A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, pegaptanib sodium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
540 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pegaptanib sodium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
24997182
Citation
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.
Results Reference
derived
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A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.
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