Diabetic Macular Oedema
Conditions
Interventions
Trade Name: Lucentis
Product Name: Ranibizumab
Product Code: RFB002
Pharmaceutical Form: Solution for injection
Sponsors
Novartis Pharmaceuticals UK Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patients = 18 years of age who have given written informed consent. 2) Patients with Type 1 or Type 2 diabetes mellitus. 3) Patients with visual impairment due to focal or diffuse DMO, and not other causes, in at least one eye who are eligible for laser treatment in the opinion of the investigator. 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. 4) BCVA between 78 and 24 in the study eye using ETDRS-like visual acuity testing charts after adjustment for the testing distance of 4 metres (approximate Snellen equivalent of 6/9 to 6/96) at screening. 5) Increased central retinal thickness which, in the opinion of the investigator, is due to DMO. 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: 1) Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to first study drug treatment. 2) Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, 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 oestrogen and/or a progestational agent. 3) 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 serum pregnancy test (hCG >5 mIU/mL). 4) Inability to comply with study procedures. 5) Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment (e.g cataract, retinal vascular occlusion, retinal detachment, macular hole, vitreomacular traction, or choroidal neovascularization of any cause e.g. AMD, ocular histoplasmosis, or pathologic myopia). 6) Active intraocular inflammation (grade trace or above) or infection (e.g. conjunctivitis, keratitis, scleritis, endophthalmitis) in either eye at enrollment . 7) History of uveitis in either eye at any time. 8) Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular oedema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques. 9) Planned medical or surgical intervention during the 18-month study period. 10) Uncontrolled glaucoma in either eye at screening (IOP > 24 mmHg on medication or according to investigator’s judgment). 11) Neovascularization of the iris in either eye. 12) Active proliferative diabetic retinopathy in the study eye. 13) Panretinal or focal/grid laser photocoagulation in the study eye within 3 months prior to Visit 2. 14) Treatment with anti-angiogenic drugs and corticosteroids in the study eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, VEGF-Trap, etc.) within 3 months prior to Visit 2 . 15) Any intraocular surgery in the study eye within 3 months prior to Visit 2. 16) History of vitrectomy in study eye. 17) Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids. 18) History of acute thromboembolic event within 4 months of screening. 19) Renal failure requiring dialysis or renal transplant OR renal insufficiency with e-GFR < 30 levels at
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy of 0.5 mg Lucentis (ranibizumab), as measured by the mean change from baseline in Best Corrected Visual Acuity (BCVA) at 12 months,; Secondary Objective: -to evaluate the efficacy of 0.5 mg Lucentis (ranibizumab), as measured by the mean change from baseline in Best Corrected Visual Acuity (BCVA) at 18 months, -to evaluate the safety of 0.5 mg Lucentis (ranibizumab), as measured by ocular and systemic adverse events at 18 months, - to evaluate the time course of BCVA changes with 0.5 mg Lucentis (ranibizumab) from 6 months to 12 and 18 months, - to evaluate the time course of changes in central retinal thickness with 0.5 mg Lucentis (ranibizumab) from baseline to 12 and 18 months, - to evaluate the time course of changes in central retinal thickness with 0.5 mg Lucentis (ranibizumab) from 6 months to 12 and 18 months, - to evaluate the time course of changes in severity of diabetic retinopathy with 0.5 mg Lucentis (ranibizumab) from baseline to 12 and 18 months, -see protocol for remaining secondary objectives- ;Primary end point(s): Mean change from baseline in Best Corrected Visual Acuity (BCVA) at 12 months.;Timepoint(s) of evaluation of this end point: - | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
United Kingdom
Contacts
Public ContactMedical Collaboration Centre
Novartis Pharmaceuticals UK Ltd
Outcome results
None listed