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.

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2005-001460-32-IT
• Date of registration: 22/12/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 15/02/2006
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001460-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: - same IMP used at different dosage Number of treatment arms in the trial: 4

Countries of recruitment

Belgium, Czech Republic, Denmark, Germany, Greece, Italy, Portugal, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
-
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

diabetic macular edema
MedDRA version: 14.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Trade Name: MACUGEN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegaptanib
Concentration unit: mg milligram(s)
Concentration number: .3-

Primary Outcome(s)

Secondary Objective: -

Main Objective: to confirm the safety and compare the efficacy of pegaptanib sodium when given as intravitreous injections of 0.3 mg/eye versus sham injections in a 1:1 ratio, respectively. All subjects previously randomized to the 0.03 or 0.003 mg/eye treatment arms during the conduct of EOP1013 through EOP1013C will be given the option of either receiving injections of 0.3 mg/eye or withdrawing from the study. Injections will be given as often as every 6 weeks for 2 years, in subjects with diabetic macular edema involving the center of the macula associated with vision loss not due to ischemia.

Primary end point(s): The proportion of subjects exhibiting an improvement of >10 letters (or 2-lines) of vision (ETDRS) from baseline. The 1 year endpoint is the primary endpoint, while the 2 year endpoint will be the secondary endpoint.

Secondary ID(s)

EOP1013B