Neovascular Age-related Macular Degeneration
Conditions
Keywords
Macugen Age-related macular degeneration (AMD) Observational study
Brief summary
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.
Interventions
DRUGMacugen
Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration * Patients having received at least 1 Macugen injection * Treatment naive patients, or patients having received conventional therapy * Patients having signed and dated informed consent.
Exclusion criteria
* Patients participating in another clinical study with Macugen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Final Visit in Visual Acuity (VA) Score | Baseline, Month 24 or Early Termination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change in VA: Stabilization | Months 3, 6, 9 and 12 | 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. |
| Number of Participants With Change in VA: Worsening | Months 3, 6, 9 and 12 | 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. |
| Number of Participants With Change in VA: Improvement | Months 3, 6, 9 and 12 | 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. |
| Frequency of Macugen Administration | Baseline up to 28.4 months | Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment. |
| Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments | Months 3, 6, 9 and 12 | Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit). |
| Duration of Treatment | Baseline up to 28.4 months | 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). |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Active choroidal neovascula increased | 1 |
| Overall Study | Adverse Event | 4 |
| Overall Study | Choroidal neovascularization | 1 |
| Overall Study | Decrease of size | 1 |
| Overall Study | Growth choroidal neovascularisation | 1 |
| Overall Study | Lack of Efficacy | 18 |
| Overall Study | Progression to fibrosis | 2 |
| Overall Study | Stabilization | 5 |
| Overall Study | Very low visual acuity (VA) | 1 |
| Overall Study | Vitreous hemorrhage | 1 |
Baseline characteristics
| Characteristic | Macugen |
|---|---|
| Age, Customized 65 to 74 years | 8 Participants |
| Age, Customized < 65 years | 3 Participants |
| Age, Customized 75 to 84 years | 22 Participants |
| Age, Customized >= 85 years | 5 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
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.
Time frame: Baseline, Month 24 or Early Termination
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macugen | Change From Baseline to Final Visit in Visual Acuity (VA) Score | -0.044 Scores on scale | Standard Deviation 0.122 |
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).
Time frame: Baseline up to 28.4 months
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macugen | Duration of Treatment | 4.66 Months | Standard Deviation 5.26 |
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.
Time frame: Baseline up to 28.4 months
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macugen | Frequency of Macugen Administration | 7.74 Weeks per injection | Standard Deviation 4.8 |
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).
Time frame: Months 3, 6, 9 and 12
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macugen | Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments | 4 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.
Time frame: Months 3, 6, 9 and 12
Population: FAS; n= number of participants with analyzable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Change in VA: Improvement | Month 3 (n=18) | 3 Participants |
| Macugen | Number of Participants With Change in VA: Improvement | Month 6 (n=5) | 1 Participants |
| Macugen | Number of Participants With Change in VA: Improvement | Month 9 (n=2) | 1 Participants |
| Macugen | Number of Participants With Change in VA: Improvement | Month 12 (n=2) | 1 Participants |
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.
Time frame: Months 3, 6, 9 and 12
Population: FAS; n= number of participants with analyzable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Change in VA: Stabilization | Month 3 (n=18) | 11 Participants |
| Macugen | Number of Participants With Change in VA: Stabilization | Month 6 (n=5) | 2 Participants |
| Macugen | Number of Participants With Change in VA: Stabilization | Month 9 (n=2) | 0 Participants |
| Macugen | Number of Participants With Change in VA: Stabilization | Month 12 (n=2) | 1 Participants |
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.
Time frame: Months 3, 6, 9 and 12
Population: FAS; n= number of participants with analyzable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Change in VA: Worsening | Month 3 (n=18) | 4 Participants |
| Macugen | Number of Participants With Change in VA: Worsening | Month 6 (n=5) | 2 Participants |
| Macugen | Number of Participants With Change in VA: Worsening | Month 9 (n=2) | 1 Participants |
| Macugen | Number of Participants With Change in VA: Worsening | Month 12 (n=2) | 0 Participants |