Age-Related Macular Degeneration (AMD)Phase 4NCT00354445
A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
A Phase 4 study testing pegaptanib sodium (Macugen) in people with Age-Related Macular Degeneration (AMD), run by Eyetech Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration (AMD)
- What is being tested?
- pegaptanib sodium (Macugen)
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to not given
- Phase
- Phase 4
- 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
- Subfoveal CNV secondary to AMD
- At least 1 but not more than 3 prior treatments for AMD
Who cannot join
- Subfoveal scar or subfoveal atrophy
- Significant media opacities, including cataract, which might interfere with visual acuity
Trial locations and contacts
1 site in 1 country.
Macugen Information contact
United States1 site, 1 recruiting
- Recruiting
Retina Research Institute of Texas, LLC
Abilene, Texas, 79606
Macugen Information, 866-622-8436
About this study
Official title: A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement
The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.
- Conditions
- Age-Related Macular Degeneration (AMD)
- Being tested
- pegaptanib sodium (Macugen)
- Keywords
- Age-Related Macular Degeneration (AMD), pegaptanib sodium, subfoveal CNV, macugen
- 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 sodium (Macugen)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular Degeneration (AMD)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Eyetech Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354445
- Sponsor's protocol ID
- EOP1023
- Status last verified
- Jan 2007
- First submitted
- 18 Jul 2006
- Last updated
- 15 Jan 2007
- Results posted
- No
Publications
Friberg TR, Tolentino M; LEVEL Study Group; Weber P, Patel S, Campbell S, Goldbaum M. Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study. Br J Ophthalmol. 2010 Dec;94(12):1611-7. doi: 10.1136/bjo.2009.174946. Epub 2010 May 14.
PubMed 20472746
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open Label, Multi-Center, Study of Maintenance Intravitreous Injections of Macugen (Pegaptanib Sodium) Given Every 6 Weeks for 48 Weeks in Subjects With Subfoveal Neovascular Age-Related Macular Degeneration (AMD) Initially Treated With a Modality Resulting in Maculopathy Improvement
- ClinicalTrials.gov ID
- NCT00354445
- Acronym / sponsor ID
- EOP1023
- Conditions
- Age-Related Macular Degeneration (AMD)
- Keywords
- Age-Related Macular Degeneration (AMD), pegaptanib sodium, subfoveal CNV, macugen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants
- Lead sponsor
- Eyetech PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jun 2006
- First posted
- 20 Jul 2006 (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.
The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.
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 (2 listed)
- Subfoveal CNV secondary to AMD
- At least 1 but not more than 3 prior treatments for AMD
Key exclusion criteria (2 listed)
- Subfoveal scar or subfoveal atrophy
- Significant media opacities, including cataract, which might interfere with visual acuity
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 (Macugen) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2007.
- Derived from this study: PubMed 20472746Friberg TR, Tolentino M; LEVEL Study Group; Weber P, Patel S, Campbell S, Goldbaum M. Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study. Br J Ophthalmol. 2010 Dec;94(12):1611-7. doi: 10.1136/bjo.2009.174946. Epub 2010 May 14.
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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.
Macugen Information contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pegaptanib sodium (Macugen) in people with Age-Related Macular Degeneration (AMD), run by Eyetech Pharmaceuticals at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Macugen Information (1-866-622-8436), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00354445, which also lists 1 linked publication.
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 15 Jan 2007.