N/A
N=1,001
Observational Study Of The Long-Term Effect Of Macugen In Patients With Wet Age-Related Macular Degeneration
Macular Degeneration · Age-related Macular Degeneration · Neovascular Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01245387 ↗Enrolled (actual)
1,001
Serious AEs
2.0%
Results posted
Jan 2011
Primary outcome: Primary: Visual Acuity (VA) — 8.51; 8.72; 8.67; 8.93 lines of VA
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pegaptanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity (VA) |
8.51; 8.72; 8.67; 8.93; 9.06; 8.83 | — |
| PRIMARY Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score |
54.05; 55.56; 57.13; 56.95; 56.09; 54.90 | — |
| PRIMARY Number of Participants With Investigator Assessments of Efficacy |
36; 226; 168; 174 | — |
| PRIMARY Lesion Size (Number of Optic Disc Areas) |
2.4; 2.1; 2.3; 2.2; 2.3; 3.2 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 |
28; 74; 88 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 |
22; 66; 85 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 |
57; 83; 176 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 |
13; 15; 18 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 |
6; 15; 24 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 |
11; 21; 46 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 42 |
3; 6; 6 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 48 |
2; 3; 5 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 54 |
0; 2; 4 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 60 |
1; 0; 1 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 66 |
0; 1; 2 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Week 72 |
0; 0; 1 | — |
| PRIMARY Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit |
101; 170; 243 | — |
| PRIMARY Number of Participants With Pigment Epithelial Detachment (PED) at Baseline |
240; 473 | — |
| PRIMARY Number of Participants With PED at Week 6 |
46; 142 | — |
| PRIMARY Number of Participants With PED at Week 12 |
32; 137 | — |
| PRIMARY Number of Participants With PED at Week 18 |
45; 268 | — |
| PRIMARY Number of Participants With PED at Week 24 |
7; 38 | — |
| PRIMARY Number of Participants With PED at Week 30 |
11; 33 | — |
| PRIMARY Number of Participants With PED at Week 36 |
11; 66 | — |
| PRIMARY Number of Participants With PED at Week 42 |
3; 12 | — |
| PRIMARY Number of Participants With PED at Week 48 |
6; 4 | — |
| PRIMARY Number of Participants With PED at Week 54 |
1; 5 | — |
| PRIMARY Number of Participants With PED at Last Visit |
87; 422 | — |
| PRIMARY Central Retinal Thickness |
309.2; 305.8; 307.3; 297.8; 328.9; 272.7 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Baseline |
76; 363; 113; 138; 26 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 6 |
29; 81; 21; 56; 3 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 12 |
29; 71; 21; 50; 2 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 18 |
68; 140; 70; 30; 8 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 24 |
7; 26; 5; 5; 2 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 30 |
10; 23; 8; 3; 1 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 36 |
5; 37; 30; 3; 3 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 42 |
3; 10; 1; 0; 1 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 48 |
0; 7; 3; 0; 0 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Week 54 |
0; 3; 3; 0; 0 | — |
| PRIMARY Number of Participants With Angiographic Subtype Reported at Last Visit |
105; 251; 88; 58; 12 | — |
Summary
Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.
Eligibility Criteria
Inclusion Criteria
- patients with neovascular age-related macular degeneration
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT01245387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.