N/A
N=108
Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice
Age-related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00787319 ↗Enrolled (actual)
108
Serious AEs
1.8%
Results posted
Aug 2013
Primary outcome: Primary: Change From Baseline in Visual Acuity (VA) at Final Visit — 0.61; 0.15 logMAR
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- no intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual Acuity (VA) at Final Visit |
0.61; 0.15 | — |
| SECONDARY Change From Baseline in Visual Acuity (VA) at Each Visit |
-0.03; 0.03; 0.03; 0.01; 0.03; 0.02 | — |
| SECONDARY Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination |
20; 64; 6; 12; 58; 18 | — |
| SECONDARY Physician's Assessment of Efficacy |
20; 16; 24; 12; 36 | — |
Summary
To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.
Eligibility Criteria
Inclusion Criteria
- age over 18 years old
- patients with neovascular age-related macular degeneration
- enrollment to study is fully on physician decision in compliance with current SPC
Exclusion Criteria
- Patient who did not meet indication according to SPC Macugen.
Data sourced from ClinicalTrials.gov (NCT00787319). 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.