N/A
Completed N=501
Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
Macular Degeneration
Source: ClinicalTrials.gov NCT00460408 ↗
Enrolled (actual)
501
Serious AEs
4.6%
Results posted
Dec 2012
Primary outcomePrimary: Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection — 1.34; 2.19; 0.48; 2.50 percent per injection
Summary
The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection |
1.34; 2.19; 0.48; 2.50; 0.10; 0.73 | — |
| PRIMARY Incidence of POAEs Per Injection Reported by Gender (Females) |
1.12; 3.19; 0.78; 3.70; 0.17; 0 | — |
| SECONDARY Incidence of POAEs Per Injection Reported by Gender (Males) |
1.67; 0; 0; 0; 0.25; 2.33 | — |
| SECONDARY Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) |
2.17; 0; 0; 0; 0.18; 0 | — |
| SECONDARY Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) |
2.04; 4.62; 0; 0; 0.11; 1.54 | — |
| SECONDARY Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) |
0.62; 0; 0.79; 5.26; 0.14; 0 | — |
| SECONDARY Number of Participants With Serious Hypersensitivity Reactions |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Neovascular AMD patients who are eligible for Macugen therapy based on the approved label
Exclusion Criteria
- Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.
Data sourced from ClinicalTrials.gov (NCT00460408). 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.