Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
NCT00088192
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Charlotte, North Carolina
- Los Angeles, California
- Bridgeport, Connecticut
- Hamden, Connecticut
- Fort Myers, Florida
- New Orleans, Louisiana
- Hagerstown, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Royal Oak, Michigan
- Kansas City, Missouri
- Concord, New Hampshire
- Belleville, New Jersey
- Teaneck, New Jersey
- Great Neck, New York
- Lakewood, Ohio
- Oklahoma City, Oklahoma
- Portland, Oregon
- Columbia, South Carolina
- McAllen, Texas
- Burlington, Vermont
- Nagoya, Aichi
- Urayasu, Chiba
- Fukuoka-shi, Fukuoka-ken
- Maebashi, Gunma
- Sapporo, Hokkaido
- Moriguchi, Osaka
- Suita, Osaka
- Otsu, Shiga
- Chiyoda-ku, Tokyo
- Shinjuku-ku, Tokyo
- Fukushima,
- Kyoto,
| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD) | ||
| Official Title ICMJE | 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) | ||
| Brief Summary | 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. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Not Applicable | ||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
| Condition ICMJE | Macular Degeneration | ||
| Intervention ICMJE | Drug: pegaptanib sodium | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* 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 | Not Provided | ||
| Original Enrollment ICMJE | Not Provided | ||
| Study Completion Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
General Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| 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 | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00088192 | ||
| Other Study ID Numbers ICMJE | EOP1010 | ||
| 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 | August 2005 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||