Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
This study has been completed.
Sponsor:
Eyetech Pharmaceuticals
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00088192
First received: July 21, 2004
Last updated: August 29, 2005
Last verified: August 2005
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Purpose
To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor’s other clinical studies with this drug for AMD, until such time as the patient’s lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.
| Condition | Intervention |
|---|---|
|
Macular Degeneration |
Drug: pegaptanib sodium |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Non-Comparative Protocol for Use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD) |
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 Eyetech Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Best corrected visual acuity in the study eye between 20/40 and 20/320.
- Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size [including blood, scar/atrophy & neovascularization] of < 12 total disc areas, of which at least 50% must be active CNV.
- Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
General Criteria:
- Patients of either gender, aged greater than 50 years.
- Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication.
- Written informed consent.
Exclusion Criteria:
- Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy.
- Patients who are eligible for PDT with Visudyne
- Patients who are eligible for any other of the Sponsor’s ongoing AMD studies still open to enrollment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088192
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Hide Study LocationsLocations
| United States, California | |
| Doheny Eye Institute | |
| Los Angeles, California, United States, 90033 | |
| United States, Connecticut | |
| Connecticut Retina Consultants, L.L.C. | |
| Bridgeport, Connecticut, United States, 06606 | |
| New England Retina Associates | |
| Hamden, Connecticut, United States, 06518 | |
| United States, Florida | |
| Retina Health Center | |
| Fort Myers, Florida, United States, 33901 | |
| United States, Louisiana | |
| Retina Associates | |
| New Orleans, Louisiana, United States, 70155 | |
| United States, Maryland | |
| Cumberland Valley Retina Center | |
| Hagerstown, Maryland, United States, 21740 | |
| United States, Massachusetts | |
| Ophthalmic Consultants of Boston | |
| Boston, Massachusetts, United States, 02114 | |
| New England Eye Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Associated Retinal Consultants | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Missouri | |
| Eye Foundation of Kansas City | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Hampshire | |
| The Eye Center of Concord | |
| Concord, New Hampshire, United States, 03301 | |
| United States, New Jersey | |
| Vitreo- Retinal Assoc. of NJ | |
| Belleville, New Jersey, United States, 07109 | |
| Retina Associates of New Jersey, P.A. | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New York | |
| L.I. Vitreo-Retinal Consultants | |
| Great Neck, New York, United States, 11021 | |
| United States, Ohio | |
| Retina Associates of Cleveland Inc. | |
| Lakewood, Ohio, United States, 44107 | |
| United States, Oklahoma | |
| Dean A. McGee Eye Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| The Casey Eye Institute | |
| Portland, Oregon, United States, 97239 | |
| United States, South Carolina | |
| Palmetto Retina Center | |
| Columbia, South Carolina, United States, 29204 | |
| United States, Texas | |
| Valley Retina Associates, P.A. | |
| McAllen, Texas, United States, 78503 | |
| United States, Vermont | |
| University of Vermont College of Medicine | |
| Burlington, Vermont, United States, 05401 | |
Sponsors and Collaborators
Eyetech Pharmaceuticals
Pfizer
More Information
Additional Information:
Sponsors Website 
No publications provided
| ClinicalTrials.gov Identifier: | NCT00088192 History of Changes |
| Other Study ID Numbers: | EOP1010 |
| Study First Received: | July 21, 2004 |
| Last Updated: | August 29, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eyetech Pharmaceuticals:
|
AMD Age-Related Macular Degeneration Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization |
Additional relevant MeSH terms:
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013