Diabetic Macular Edema (DME) MedDRA version: 9.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) See Exploratory objectives in the protocol page 12. ;Primary end point(s): The primary analysis will be the estimation of incidences of adverse events. | — |
Countries
Belgium, France, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed