An observational study in Neovascular Age-related Macular Degeneration, sponsored by Pfizer. Completed at 8 sites in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-04-11.
Sponsored by Pfizer · Observational
Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.
Eligible patients in routine clinical practice
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 86 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with Age-related Macula degeneration
adults with neovascular age-related macula degeneration
Exclusion Criteria:
according to SmPC
Drug: pegaptanib sodium
pegaptanib sodium intravitreal injection every 6 weeks for 2 years
Change From Baseline Visual Acuity (VA) at the Final Visit
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Time frame: Baseline, Week 102 or Early Termination (ET)
Change From Baseline VA at Each Visit
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Time frame: Baseline, every 6 weeks up to Week 102
Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the "Pigment Epithelial Detachment (PED) present" box ticked at Baseline Visit.
Time frame: Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Time frame: Baseline, Month 6, 12, 18, and 24
Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Time frame: Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.
Time frame: Baseline, Week 102 or ET
Change From Baseline VA at Final Visit by Age Group
Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to \[\>=\] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
Time frame: Baseline, Week 102 or ET
Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
Time frame: Baseline, Week 102 or ET
Change From Baseline VA at the Final Visit by Previous Treatment of AMD
Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
Time frame: Baseline, Week 102 or ET
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.
Time frame: Every 6 weeks up to Week 102
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.
Time frame: Every 6 weeks up to Week 102
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.
Time frame: Every 6 weeks up to Week 102
Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study
Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).
Time frame: Baseline through Week 102
Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)
IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.
Time frame: Baseline and Week 102 or ET
| Milestone | Pegaptanib |
|---|---|
| Started | 85 |
| Completed | 6 |
| Not completed | 79 |
| Withdrew: Adverse event | 3 |
| Withdrew: Lost to follow-up | 26 |
| Withdrew: Participant refused | 40 |
| Withdrew: Other | 10 |
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
| logMAR | Pegaptanib |
|---|---|
| Baseline | 0.829 ± 0.367 |
| Change at Week 102/ET | -0.126 ± 0.371 |
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
| logMAR | Pegaptanib |
|---|---|
| Change at Week 6 (n=59) | -0.07 ± 0.249 |
| Change at Week 12 (n=56) | -0.10 ± 0.297 |
| Change at Week 18 (n=48) | -0.12 ± 0.374 |
| Change at Week 24 (n=43) | -0.16 ± 0.406 |
| Change at Week 30 (n=37) | -0.16 ± 0.415 |
| Change at Week 36 (n=31) | -0.17 ± 0.416 |
| Change at Week 42 (n=28) | -0.12 ± 0.455 |
| Change at Week 48 (n=25) | -0.13 ± 0.472 |
| Change at Week 54 (n=23) | -0.07 ± 0.461 |
| Change at Week 60 (n=19) | -0.09 ± 0.500 |
| Change at Week 66 (n=13) | 0.04 ± 0.558 |
| Change at Week 72 (n=10) | 0.05 ± 0.495 |
| Change at Week 84 (n=8) | -0.04 ± 0.302 |
| Change at Week 90 (n=4) | -0.11 ± 0.334 |
| Change at Week 96 (n=2) | 0.33 ± 0.213 |
| Change at Week 102 (n=2) | 0.33 ± 0.213 |
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the "Pigment Epithelial Detachment (PED) present" box ticked at Baseline Visit.
| logMAR | Pegaptanib |
|---|---|
| Baseline | 0.804 ± 0.386 |
| Change at Week 102/ET | -0.105 ± 0.443 |
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
| scores on a scale | Pegaptanib |
|---|---|
| Baseline (n=30) | 67.73 ± 21.126 |
| Change at Month 6 (n=19) | 2.62 ± 10.647 |
| Change at Month 12 (n=13) | 4.22 ± 9.596 |
| Change at Month 18 (n=4) | -2.33 ± 1.549 |
| Change at Month 24 (n=2) | -2.56 ± 9.241 |
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
| scores on a scale | Pegaptanib |
|---|---|
| Baseline | 69.47 ± 21.62 |
| Change at Week 102/ET | 3.21 ± 12.78 |
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.
| scores on a scale | Pegaptanib |
|---|---|
| General Health, Change at Week 102/ET (n=59) | -1.69 ± 22.198 |
| General Vision, Change at Week 102/ET (n=59) | 5.08 ± 16.014 |
| Ocular Pain, Change at Week 102/ET (n=59) | -4.87 ± 15.746 |
| Near Activities, Change at Week 102/ET (n=59) | 5.93 ± 21.709 |
| Distance Activities, Change at Week 102/ET (n=59) | 0.71 ± 20.532 |
| Social Functioning, Change at Week 102/ET (n=59) | 1.91 ± 22.602 |
| Mental Health, Change at Week 102/ET (n=59) | 3.81 ± 18.461 |
| Role Difficulties, Change at Week 102/ET (n=59) | 4.45 ± 17.794 |
| Dependency, Change at Week 102/ET (n=59) | 6.07 ± 18.751 |
| Driving, Change at Week 102/ET (n=20) | -2.50 ± 14.075 |
| Color Vision, Change at Week 102/ET (n=57) | 3.07 ± 20.084 |
| Peripheral Vision, Change at Week 102/ET (n=59) | 5.08 ± 19.575 |
Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to \[\>=\] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
| logMAR | Pegaptanib |
|---|---|
| 51-64 years, Baseline (n=10) | 0.797 ± 0.361 |
| 51-64 years, Change at Week 102/ET (n=10) | -0.156 ± 0.253 |
| ≥ 65 years, Baseline (n=57) | 0.835 ± 0.371 |
| ≥ 65 years, Change at Week 102/ET (n=57) | -0.121 ± 0.390 |
Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
| logMAR | Pegaptanib |
|---|---|
| Early Lesion, Baseline (n=34) | 0.704 ± 0.332 |
| Early Lesion, Change at Week 102/ET (n=34) | -0.066 ± 0.395 |
| Late Stage Lesion, Baseline (n=31) | 0.961 ± 0.358 |
| Late Stage Lesion, Change at Week 102/ET (n=31) | -0.190 ± 0.348 |
| Other AMD Stage, Baseline (n=1) | 1.301 ± NA |
| Other AMD Stage, Change at Week 102/ET (n=1) | -0.301 ± NA |
Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
| scores on a scale | Pegaptanib |
|---|---|
| No Previous AMD Treatment, Baseline (n=62) | 0.838 ± 0.363 |
| No Previous Treatment, Change at Week 102/ET(n=62) | -0.126 ± 0.367 |
| Previous AMD Treatment, Baseline (n=5) | 0.724 ± 0.438 |
| Previous Treatment, Change at Week 102/ET (n=5) | -0.120 ± 0.461 |
Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.
| participants | Pegaptanib |
|---|---|
| Week 6 | 8 |
| Week 12 | 7 |
| Week 18 | 6 |
| Week 24 | 7 |
| Week 30 | 11 |
| Week 36 | 4 |
| Week 42 | 3 |
| Week 48 | 4 |
| Week 54 | 2 |
| Week 60 | 4 |
| Week 66 | 2 |
| Week 72 | 0 |
| Week 78 | 0 |
| Week 84 | 1 |
| Week 90 | 1 |
| Week 96 | 0 |
| Week 102 | 1 |
Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.
| participants | Pegaptanib |
|---|---|
| Week 6 | 32 |
| Week 12 | 35 |
| Week 18 | 34 |
| Week 24 | 31 |
| Week 30 | 24 |
| Week 36 | 26 |
| Week 42 | 21 |
| Week 48 | 17 |
| Week 54 | 16 |
| Week 60 | 16 |
| Week 66 | 10 |
| Week 72 | 6 |
| Week 78 | 0 |
| Week 84 | 7 |
| Week 90 | 5 |
| Week 96 | 1 |
| Week 102 | 1 |
Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.
| participants | Pegaptanib |
|---|---|
| Week 6 | 0 |
| Week 12 | 0 |
| Week 18 | 0 |
| Week 24 | 0 |
| Week 30 | 0 |
| Week 36 | 1 |
| Week 42 | 0 |
| Week 48 | 0 |
| Week 54 | 0 |
| Week 60 | 0 |
| Week 66 | 0 |
| Week 72 | 0 |
| Week 78 | 0 |
| Week 84 | 0 |
| Week 90 | 0 |
| Week 96 | 0 |
| Week 102 | 0 |
Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).
| participants | Pegaptanib |
|---|---|
| Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study | 3 |
IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.
| millimeters of mercury (mmHg) | Pegaptanib |
|---|---|
| Baseline (n=78) | 15.0 ± 3.2 |
| Pre-dose, Change at Week 102/ET (n=74) | 0.3 ± 2.7 |
| Post-dose, Change at Week 102/ET (n=75) | 0.8 ± 3.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegaptanib | — | 1/85 (1.2%) | 5/85 (5.9%) |
| Event | Pegaptanib |
|---|---|
| Intestinal polypGastrointestinal disorders | 1/85 |
| Event | Pegaptanib |
|---|---|
| Retinal tearEye disorders | 1/85 |
| UveitisEye disorders | 1/85 |
| AstheniaGeneral disorders | 1/85 |
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 1/85 |
| DizzinessNervous system disorders | 1/85 |
| RashSkin and subcutaneous tissue disorders | 1/85 |
| Age Continuous(years) | Pegaptanib |
|---|---|
| Mean | 74.0 ± 6.8 |
| Sex: Female, Male(Participants) | Pegaptanib |
|---|---|
| Female | 44 |
| Male | 41 |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline(scores on a scale) | Pegaptanib |
|---|---|
| General Health (n=85) | 45.00 ± 23.081 |
| General Vision (n=85) | 55.53 ± 16.439 |
| Ocular Pain (n=85) | 80.74 ± 20.912 |
| Near Activities (n=85) | 53.09 ± 28.976 |
| Distance Activities (n=85) | 58.73 ± 28.264 |
| Social Functioning (n=85) | 72.35 ± 28.809 |
| Mental Health (n=85) | 50.51 ± 24.056 |
| Role Difficulties (n=85) | 57.06 ± 31.425 |
| Dependency (n=85) | 61.27 ± 28.542 |
| Driving (n=30) | 49.72 ± 35.523 |
| Color Vision (n=83) | 79.82 ± 23.896 |
| Peripheral Vision (n=85) | 67.65 ± 29.586 |
| Procedures used for age-related macular degeneration (AMD) diagnosis(participants) | Pegaptanib |
|---|---|
| fluorescein angiography | 66 |
| indocyanine green angiography | 0 |
| optical coherence tomography | 18 |
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer