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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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 |
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Recruitment Status :
Completed
First Posted : May 4, 2006
Last Update Posted : May 4, 2006
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Sponsor:
Eyetech Pharmaceuticals
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 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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| 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. | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE |
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. |
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| Sex/Gender ICMJE |
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| 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 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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