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 - RESTORE EXTENSION

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2008-007467-17-HU
• Date of registration: 08/07/2009
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• 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 - RESTORE EXTENSION
• 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 - RESTORE EXTENSION
• Date of first enrolment: 24/09/2009
• 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: yes 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:
1. Patients must have completed the RESTORE study assessments at Month 12

2. Patients must give written informed consent before any study related activity of
this extension protocol 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:
a. Use of investigational drugs, other than those provided in RESTORE
(RFB002D2301) study at the time of enrollment, or within 30 days or 5 half-lives of
enrollment, whichever is longer
b. Current use or likely need of systemic medications known to be toxic to the lens,
retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine
(Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
c. History of hypersensitivity to ranibizumab or any component of the ranibizumab
formulation
d. Uncontrolled glaucoma in either eye ( IOP > 24 mmHg on medication or according
to investigator’s judgment)
e. Evidence of vitreomacular traction in either eye at visit 14
f. Active proliferative diabetic retinopathy in the study eye at visit 14
g. Intravitreal corticosteroid treatment in a phakic study eye during the core study
h. Intravitreal corticosteroids in post-cataract surgical study eye (aphakic or
pseudophakic without damaged posterior capsule) within 3 months prior to Visit
14
i. Ocular conditions in the study eye that require chronic concomitant therapy with
topical ocular corticosteroids at visit 14
j. Any type of advanced, severe or unstable disease or its treatment, that could
interfere with primary and/or secondary outcome evaluations including any
medical condition that could be expected to progress, recur, or change to such an
extend that it may bias the assessment of the clinical status of the patient to a
significant degree or put the patient at special risk
k. History of stroke or transient ischemic attack (TIA)
l. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, UNLESS they are using two birth control methods. The two
methods can be a double barrier method or a barrier method plus a hormonal
method. Adequate barrier methods of contraception include: diaphragm, condom
(by the partner), intrauterine device (copper or hormonal), sponge or spermicide.
Hormonal contraceptives include any marketed contraceptive agent that includes
an estrogen and/or a progestational agent.
m. Pregnant or nursing (lactating) women, where pregnancy is defined as the state
of a female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test (> 5 mIU/mL)
n. Inability to comply with study or follow-up procedures.

No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.



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

Health Condition(s) or Problem(s) studied

Diabetic Macular Edema (DME)
MedDRA version: 9.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema

Intervention(s)

Trade Name: Lucentis
Product Name: Lucentis
Product Code: RFB002D
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

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

Main Objective: The primary objective of this trial is to evaluate the ocular and non-ocular adverse events during the 24-months study period in patients treated with Lucentis (0.5 mg)

Secondary Objective: Secondary objectives are:

• 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)

RFB002D2301E1

2008-007467-17-FR