Trial · NCT01245387
Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration
NCT01245387, Completed, Pfizer; results first posted 2011-01-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration. Trials, record NCT01245387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01245387
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration
- NCT number
- NCT01245387
- Status
- Completed
- Enrollment
- 1,001 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Macular Degeneration, Age-related Macular Degeneration, Neovascular Macular Degeneration
- Interventions
- Pegaptanib
- First posted
- 2010-11-22
- Last updated
- 2011-01-13
- Results first posted
- 2011-01-07
- Limitations and caveats
Time to first AE not estimated due to insufficient number of events. Visit numbers for NEI-VFQ-25 deviated from numbering used in other analyses; it represents the sequence number of questionaries administered (Visit 1=first assessment, etc.).
Source ClinicalTrials.gov
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Acuity (VA) | Baseline, every 6 weeks up to Month 24 or early termination | VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study \[EDTRS\]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection). |
| Primary | Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Baseline, every 6 months up to Month 24 or early termination | Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. |
| Primary | Number of Participants With Investigator Assessments of Efficacy | Month 24 or early termination | Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor. |
| Primary | Lesion Size (Number of Optic Disc Areas) | Baseline, every 6 weeks up to Month 24 or early termination | Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm\^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection). |
| Primary | Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 | Week 6 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Primary | Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 | Week 12 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Primary | Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 | Week 18 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Primary | Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 | Week 24 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Primary | Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 | Week 30 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Primary | Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 | Week 36 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 registered outcomesOutcomes46
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Acuity (VA) | Baseline, every 6 weeks up to Month 24 or early termination | Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value. | lines of VA | MEAN |
| PRIMARY | Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Baseline, every 6 months up to Month 24 or early termination | FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value. | Scores on a scale | MEAN |
| PRIMARY | Number of Participants With Investigator Assessments of Efficacy | Month 24 or early termination | FAS; N = number of participants with evaluable data. | Participants | NUMBER |
| PRIMARY | Lesion Size (Number of Optic Disc Areas) | Baseline, every 6 weeks up to Month 24 or early termination | FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value. | number of optic disc areas | MEAN |
| PRIMARY | Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 | Week 6 | FAS; N=number of participants with evaluable data. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 | Week 12 | FAS; N=number of participants with evaluable data. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 | Week 18 | FAS; N=number of participants with evaluable data. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 | Week 24 | FAS; N=number of participants with evaluable data. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 | Week 30 | FAS; N=number of participants with evaluable data. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 | Week 36 | FAS; N=number of participants with evaluable data. | Participants | NUMBER |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 outcomesResults by group199
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Acuity (VA) | Macugen | Visit 1, Baseline (N=812) | 8.51 | Standard Deviation 5.03 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 2, Week 0, first injection (N=812) | 8.72 | Standard Deviation 5.19 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 3, Week 6 (N=785) | 8.67 | Standard Deviation 4.90 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 4, Week 12 (N=684) | 8.93 | Standard Deviation 4.97 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 5, Week 18 (N=537) | 9.06 | Standard Deviation 4.81 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 6, Week 24 (N=253) | 8.83 | Standard Deviation 5.32 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 7, Week 30 (N=203) | 8.60 | Standard Deviation 4.69 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 8, Week 36 (N=133) | 8.07 | Standard Deviation 3.81 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 9, Week 42 (N=86) | 8.35 | Standard Deviation 3.42 | lines of VA |
| Visual Acuity (VA) | Macugen | Visit 10, Week 48 (N=54) | 8.33 | Standard Deviation 3.44 | lines of VA |
1 to 10 of 199Source ClinicalTrials.gov
See all 199 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Macugen | 1,001 | |
| Overall Study | COMPLETED | Macugen | 188 | |
| Overall Study | NOT COMPLETED | Macugen | 813 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Visual acuity reduced | Eye disorders | Macugen | 6 | 816 | |
| other | Retinal haemorrhage | Eye disorders | Macugen | 1 | 816 | |
| other | Choroidal neovascularisation | Eye disorders | Macugen | 1 | 816 | |
| other | Retinal detachment | Eye disorders | Macugen | 1 | 816 | |
| other | Detachment of retinal pigment epithelium | Eye disorders | Macugen | 1 | 816 | |
| other | Glaucoma | Eye disorders | Macugen | 1 | 816 | |
| other | Subretinal fibrosis | Eye disorders | Macugen | 1 | 816 | |
| other | Vitreous haemorrhage | Eye disorders | Macugen | 1 | 816 | |
| other | Endophthalmitis | Infections and infestations | Macugen | 1 | 816 | |
| other | Intraocular pressure increased | Investigations | Macugen | 2 | 816 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Macugen | ||
| Total, other adverse events | Macugen | 12 | 816 |
| Total, serious adverse events | Macugen | 16 | 816 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01245387
GET https://conductscience.org/api/trials/v1/NCT01245387/registered?page=2