A randomized, double-masked, multicenter, phase II study assessing the safety and efficacy of two concentrations of ranibizumab (intravitreal injections) compared with non-treatment control for the treatment of diabetic macular edema with center involvement - RESOLVE
- Conditions
- Male and female patients >18 years of age with either type 1 or type 2 diabetes mellitus with stable HbA1c levels between 6.5 and 10% and diabetic macular edema with center involvement in at least one eye.
- Registration Number
- EUCTR2005-000487-11-DE
- Lead Sponsor
- ovartis Pharma Service AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1.Male or female patients >18 years of age who have signed an informed consent
2.Patients with type 1 or type 2 diabetes mellitus diagnosed =24 months prior to screening with HbA1c not more than 12.0 % at Visit 1 and a documented history of stable HbA1c as compared to the previous measurement performed within the last 6 months with a difference of not more than 1.0 %-points. Any one of the following will be considered to be sufficient evidence that diabetes is present
•Current regular use of insulin for the treatment of diabetes
•Current regular use of oral antihyperglycemia agents for the treatment of diabetes
•Documented diabetes by ADA and/or WHO criteria
3.Patients with diabetic macular edema with center involvement in at least one eye, including those with focal or diffuse DME, as demonstrated with stereoscopic fundus photography, fluorescein angiography and optical coherence tomography within 28 days of the baseline treatment. For this eye to achieve eligibility statue it must fulfill the following three criteria at Visit 1:
•The central macular thickness must be =300 µm in the center subfield, as assessed by OCT and confirmed by the central reading center;
•BCVA score between 69 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/40 to 20/160);
•Decrease in vision is due to foveal thickening from DME and not due to other causes, in the opinion of the investigator.
5.Only one eye will be selected for study treatment (study eye). If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment. The medical reason for selecting the study eye having the better visual acuity must be described in the eCRF
6.Patients for whom, in the opinion of the investigator, laser photocoagulation in the study eye can be withheld for at least 3 months after randomization
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
1.A condition that in the opinion of the investigator would preclude a patient’s participation in the study, e.g., unstable medical status including glycemic control and blood pressure. Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled. Patients with hypertension for whom a change in antihypertensive treatment was initiated within 2 months preceding Day 1 should not be enrolled unless blood pressure is maintained for at least 1 month prior Day 1 below 160/100 mm Hg by antihypertensive treatment
2.History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week
3.Panretinal, focal peripheral laser photocoagulation within six months prior to study entry.
4.Grid/central focal laser photocoagulation is excluded except for patients with only mild laser burns at least 1000µm from the center of the fovea performed more than 6 months preceding Day 1.
5.Proliferative diabetic retinopathy in the study eye, with the exception of tufts of neovascularization less than one disc area with no vitreous hemorrhage.
6.Area of retinal ischemia =500 µm and located =500 µm from the center of the macula of the study eye as assessed by fluorescein angiography at Visit 1 and confirmed by a central reading center
7.Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye
8.Cataract surgery in the study eye within the past 6 months, Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within the past 6 months, or any intraocular surgery within the past 6 months preceding Day 1
9.Aphakia or absence of the posterior capsule in the study eye
10.History of uncontrolled glaucoma (defined as intraocular pressure =25 mm Hg despite treatment with anti-glaucoma medication) or low tension glaucoma in the study eye
12.History of chronic renal failure requiring dialysis or kidney transplant
13.Pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; an IUD; or contraceptive hormone implant or patch
14.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)
15.Current treatment for active systemic infection
16.Use of anticoagulants during the study, e.g., coumadin, warfarin, heparin. The use of aspirin is not an exclusion
17.History of allergy to fluorescein, not amenable to treatment
18.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
19.Inability to comply with study or follow-up procedures
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