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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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