Macular DegenerationNCT00088192
Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
A study testing pegaptanib sodium in people with Macular Degeneration, run by Eyetech Pharmaceuticals at 20 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- pegaptanib sodium
- How many people
- Not given
- Where
- 20 sitesUnited States
- Study dates
- Jul 2004to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Vitreo- Retinal Assoc. of NJ
Belleville, New Jersey, 07109
New England Eye Center
Boston, Massachusetts, 02111
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Connecticut Retina Consultants, L.L.C.
Bridgeport, Connecticut, 06606
University of Vermont College of Medicine
Burlington, Vermont, 05401
Palmetto Retina Center
Columbia, South Carolina, 29204
The Eye Center of Concord
Concord, New Hampshire, 03301
Retina Health Center
Fort Myers, Florida, 33901
L.I. Vitreo-Retinal Consultants
Great Neck, New York, 11021
Cumberland Valley Retina Center
Hagerstown, Maryland, 21740
New England Retina Associates
Hamden, Connecticut, 06518
Eye Foundation of Kansas City
Kansas City, Missouri, 64108
Retina Associates of Cleveland Inc.
Lakewood, Ohio, 44107
Doheny Eye Institute
Los Angeles, California, 90033
Valley Retina Associates, P.A.
McAllen, Texas, 78503
Retina Associates
New Orleans, Louisiana, 70155
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104
The Casey Eye Institute
Portland, Oregon, 97239
Associated Retinal Consultants
Royal Oak, Michigan, 48073
Retina Associates of New Jersey, P.A.
Teaneck, New Jersey, 07666
About this study
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)
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.
- Conditions
- Macular Degeneration
- Being tested
- pegaptanib sodium
- Keywords
- AMD, Age-Related Macular Degeneration, Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegaptanib sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2004 (estimated)
- Study startJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Eyetech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088192
- Sponsor's protocol ID
- EOP1010
- Status last verified
- Aug 2005
- First submitted
- 21 Jul 2004
- Last updated
- 30 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00088192
- Acronym / sponsor ID
- EOP1010
- Conditions
- Macular Degeneration
- Keywords
- AMD, Age-Related Macular Degeneration, Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eyetech PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2004
- First posted
- 22 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegaptanib sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2005.
- Sponsors WebsiteLink provided by the sponsor.
Related trials for Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pegaptanib sodium in people with Macular Degeneration, run by Eyetech Pharmaceuticals at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2005.