Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150202
First received: September 6, 2005
Last updated: May 4, 2007
Last verified: November 2006
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Purpose
This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Drug: pegaptanib sodium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Pegaptanib sodium
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.
Secondary Outcome Measures:
- Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.
| Estimated Enrollment: | 90 |
| Study Start Date: | July 2004 |
| Study Completion Date: | October 2006 |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Wet AMD, Visual Acuity from 20/320 to 20/40
Exclusion Criteria:
- Diabetic retinopathy, laser coagulation history
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150202
Locations
| Japan | |
| Pfizer Investigational Site | |
| Nagoya, Aichi, Japan, 466-8560 | |
| Pfizer Investigational Site | |
| Urayasu-shi, Chiba-ken, Japan, 279-0021 | |
| Pfizer Investigational Site | |
| Tokyo, Chiyoda-ku, Japan | |
| Pfizer Investigational Site | |
| Fukuoka-shi, Fukuoka-ken, Japan, 812-8582 | |
| Pfizer Investigational Site | |
| Maebashi, Gunma, Japan, 371-8511 | |
| Pfizer Investigational Site | |
| Sapporo, Hokkaido, Japan, 060-8604 | |
| Pfizer Investigational Site | |
| Kida-gun, Kagawa, Japan, 761-0793 | |
| Pfizer Investigational Site | |
| Moriguchi, Osaka, Japan, 570-8506 | |
| Pfizer Investigational Site | |
| Suita, Osaka, Japan, 565-0871 | |
| Pfizer Investigational Site | |
| Otsu, Shiga, Japan, 520-2192 | |
| Pfizer Investigational Site | |
| Mitaka, Tokyo, Japan, 181-8611 | |
| Pfizer Investigational Site | |
| Shinjuku-ku, Tokyo, Japan, 160-8582 | |
| Pfizer Investigational Site | |
| Fukushima, Japan, 960-1295 | |
| Pfizer Investigational Site | |
| Kyoto, Japan, 606-8507 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00150202 History of Changes |
| Other Study ID Numbers: | A5751010 |
| Study First Received: | September 6, 2005 |
| Last Updated: | May 4, 2007 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Macular Degeneration Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases |
Choroid Diseases Uveal Diseases Neovascularization, Pathologic Metaplasia Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013