N/A
Completed N=85
Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
Source: ClinicalTrials.gov NCT00858208 ↗Enrolled (actual)
85
Serious AEs
1.2%
Results posted
Apr 2012
Primary outcomePrimary: Change From Baseline Visual Acuity (VA) at the Final Visit — 0.829; -0.126 logMAR — p=0.0072
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Visual Acuity (VA) at the Final Visit |
0.829; -0.126 | 0.0072 sig |
| SECONDARY Change From Baseline VA at Each Visit |
-0.07; -0.10; -0.12; -0.16; -0.16; -0.17 | 0.0433 sig |
| SECONDARY Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED) |
0.804; -0.105 | — |
| SECONDARY Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit |
67.73; 2.62; 4.22; -2.33; -2.56 | 0.2970 |
| SECONDARY Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit |
69.47; 3.21 | 0.2759 |
| SECONDARY Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit |
-1.69; 5.08; -4.87; 5.93; 0.71; 1.91 | — |
Eligibility Criteria
Inclusion Criteria
adults with neovascular age-related macula degeneration
Exclusion Criteria
according to SmPC
Data sourced from ClinicalTrials.gov (NCT00858208). 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. Informational only — not medical advice.