An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial - ND

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2008-007467-17-IT
• Date of registration: 17/06/2009
• Prospective Registration: Yes
• Primary sponsor: NOVARTIS FARMA
• Public title: An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial - ND
• Scientific title: An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial - ND
• Date of first enrolment: 20/10/2009
• Target sample size: 320
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007467-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium, France, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Patients must have completed the RESTORE study assessments at month 12 Patients must give written informed consent before any study related activity is performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
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:
Use of other investigational drugs Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve History of hypersensitivity to ranibizumab or any component of the ranibizumab formulation Uncontrolled glaucoma in either eye Evidence of vitreomacular traction in either eye at visit 14 Active proliferative diabetic retinopathy in the study eye at visit 14 Intravitreal corticosteroid treatment in a phakic study eye during the core study Intravitreal corticosteroids in post-cataract surgical study eye (aphakic or pseudophakic without damaged posterior capsule) within 3 months prior to Visit 14 Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular corticosteroids at visit 14 Any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk History of stroke or transient ischemic attack (TIA) Women of child-bearing potential, UNLESS they are using two birth control methods Pregnant or nursing (lactating) women Inability to comply with study or follow-up procedures.


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

Health Condition(s) or Problem(s) studied

Diabetic macular edema
MedDRA version: 12.0 Level: LLT Classification code 10057915 Term: Diabetic macular oedema

Intervention(s)

Trade Name: LUCENTIS
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ranibizumab
Concentration unit: µl microlitre(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: To evaluate the ocular and non-ocular adverse events during the 24-months study period in patients treated with Lucentis (0.5 mg)

Primary end point(s): The primary analysis will be the estimation of adverse events.

Secondary Objective: To describe the ocular and non-ocular adverse events over a cumulative 36-months period - including the core and extension study - in patients treated with Lucentis (0.5 mg) To evaluate the change of the best-corrected visual acuity (BCVA) over the 24-months study period in patients treated with Lucentis (0.5 mg) To evaluate the change of the best-corrected visual acuity (BCVA) over 36-months study period- including the core and the extension study in patients treated with Lucentis (0.5 mg)

Secondary ID(s)

CRFB002D2301E1

2008-007467-17-FR