Clinical Trial Results:
A phase 2/3 randomized, controlled, double-masked, multicenter, comparative trial, in parallel groups, to compare the safety and efficacy of intravitreous injections of 0.3 mg pegaptanib sodium (Macugen), given as often as every 6 weeks for 2 years, to sham injections in subjects with diabetic macular edema (DME) involving the center of the macula with an openlabel Macugen year 3 extension.
Summary
|
|
EudraCT number |
2005-001460-32 |
Trial protocol |
IT AT DK ES GB PT BE DE GR CZ |
Global completion date |
15 Jul 2011
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
08 Jul 2016
|
First version publication date |
01 Feb 2015
|
Other versions |
|
Summary report(s) |
Public Disclosure Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.