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To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients who obtained reimbursement of Macugen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macugen | Drug | Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Final Visit in Visual Acuity (VA) Score | Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight. | Baseline, Month 24 or Early Termination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change in VA: Improvement | Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits. | Months 3, 6, 9 and 12 |
| Number of Participants With Change in VA: Stabilization |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who obtained reimbursement for Macugen, recruited by retina specialists from ophthalmology centres with experience in intravitreal injections.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Aarschot | 3200 | Belgium | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Macugen | Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Macugen | Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Final Visit in Visual Acuity (VA) Score | Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight. | The Full Analysis Set (FAS) was derived from the set of all enrolled participants who were administered at least 1 injection of the study medication and had at least 1 post Baseline efficacy measurement. Participants analyzed refers to number of participants with analyzable data. | Posted | Mean | Standard Deviation | Scores on scale | Baseline, Month 24 or Early Termination |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macugen | Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myodesopsia | Eye disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
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Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits. |
| Months 3, 6, 9 and 12 |
| Number of Participants With Change in VA: Worsening | Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits. | Months 3, 6, 9 and 12 |
| Duration of Treatment | Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen). | Baseline up to 28.4 months |
| Frequency of Macugen Administration | Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment. | Baseline up to 28.4 months |
| Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments | Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit). | Months 3, 6, 9 and 12 |
| Deurne |
| 2100 |
| Belgium |
| Pfizer Investigational Site | Leuven | 3000 | Belgium |
| Pfizer Investigational Site | Liège | 4000 | Belgium |
| Progression to fibrosis |
|
| Decrease of size |
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| Active choroidal neovascula increased |
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| Vitreous hemorrhage |
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| Growth choroidal neovascularisation |
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| Choroidal neovascularization |
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| Very low visual acuity (VA) |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Change in VA: Improvement | Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits. | FAS; n= number of participants with analyzable data. | Posted | Number | Participants | Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Number of Participants With Change in VA: Stabilization | Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits. | FAS; n= number of participants with analyzable data. | Posted | Number | Participants | Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Number of Participants With Change in VA: Worsening | Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits. | FAS; n= number of participants with analyzable data. | Posted | Number | Participants | Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Duration of Treatment | Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen). | FAS | Posted | Mean | Standard Deviation | Months | Baseline up to 28.4 months |
|
|
|
| Secondary | Frequency of Macugen Administration | Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment. | FAS | Posted | Mean | Standard Deviation | Weeks per injection | Baseline up to 28.4 months |
|
|
|
| Secondary | Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments | Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit). | FAS | Posted | Number | Participants | Months 3, 6, 9 and 12 |
|
|
|
| 0 |
| 38 |
| 2 |
| 38 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
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| Month 12 (n=2) |
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| Title | Measurements |
|---|---|
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| Month 12 (n=2) |
|
| Title | Measurements |
|---|---|
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| Month 12 (n=2) |
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