Leeftijdsgebonden macula degeneratie Diabetisch retinopathie
Conditions
Interventions
1. 1.25 mg of bevacizumab
2. 0.5 mg ranibizumab.
Given as monthly intravitreal injections during 6 months.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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 (according to American Diabetes Association or World Health Organization (WHO) guidelines) with glycosylated haemoglobin (HbA1c) less than 12.0% at screening (Visit 1). Patients should be on a dietary, exercise and/or pharmacological program for diabetes. Treatment for diabetes must have been stable for at least 2 months; 3. Patients with visual impairment due to DME (within the EDTRS criteria of clinically significant macular edema) in at least one eye, with a central area thickness >275 ìm, who are eligible for anti-VEGF treatment according to the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at visit 1, will be selected by the investigator as the study eye; 4. BCVA equal or more than 24 and less or equal to 78 letters in the study eye at screening using ETDRS- like visual acuity testing charts at a testing distance of 4 meter (approximate Snellen equivalent of 20/32 to 20/320).
Exclusion criteria
Exclusion criteria: 1. 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 estrogen and/or a progestational agent; 2. 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 (human chorionic gonadotropin > 5 mIU/ml); 3. Inability to comply with study procedures; 4. Active intraocular inflammation (grade + or above) in either eye at enrolment; 5. Any active infection (e.g., conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrolment; 6. History of uveitis in either eye at any time; 7. Structural damage within 600 m of the centre of the macula in the study eye likely to preclude improvement in visual acuity following in the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques; 8. Uncontrolled glaucoma in the study eye at screening (IOP > 24 mmHg on medication or according to investigator’s judgment); 9. Neovascularization of the iris in the study eye; 10. Evidence of vitreomacular traction in the study eye; 11. Active untreated proliferative diabetic retinopathy in the study eye; 12. Any intraocular surgery in the study eye within 3 months prior to randomization; 13. History of vitrectomy in study eye regardless of time prior to randomization; 14. Planned medical or surgical intervention during the 6 months study period; 15. Panretinal laser photocoagulation in the study eye within 3 months prior to or during the study; 16. Focal/grid laser photocoagulation in the study eye 3 months prior to study entry; 17. Treatment with anti-angiogenic drugs in the study eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, VEGF-Trap, etc.) within 3 months prior to randomization; 18. Use of other investigational drugs at the time of enrolment, or within 3 month or 5 half-lives from enrolment, whichever is longer; 19. History of intravitreal corticosteroids in phakic eye within 18 months prior to randomization or in post-cataract surgery study eye (aphakic or pseudophakic, without damaged posterior capsule) within 4 months prior to randomization; 20. Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids; 21. History of stroke or transient ischemic attack (TIA) within 6 months prior to enrolment; 22. Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels > 2.0 mg/dl at screening; 23. Blood pressure systolic > 165 mm Hg or diastolic > 105 mmHg at screening and randomization; 24. Hypertension or cha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the change in best-corrected visual acuity (BCVA) in the study eye from Baseline to Month 6 assessed with ETDRS-like VA charts at an initial distance of 4 meter. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients with a loss of BCVA less than 15 letters from baseline at 6 months (responders); 2. The proportion of patients with a loss or gain of BCVA less than 15 letters from baseline at 6 months (stabilizers); 3. The proportion of patients with 15 letters loss or more of BCVA from baseline at 6 months (non-responders); 4. The proportion of patients with 15 letters gain or more of BCVA from baseline at 6 months (gainers); 5. The incidence of fluorescein leakage at 6 months as well as the change from baseline at 6 months as determined by the reading centre; 6. Absolute and percent change in retinal thickness, as measured by optical coherence tomography (OCT) at 6 months as determined by the reading centre; 7. Proportion of dropouts before the final 6 months assessments; 8. The occurrence of (serious) adverse events during the 6 months of the study; 9. Costs of the two treatments (see economic evaluation). | — |
Contacts
Public ContactR.O. Schlingemann
Outcome results
None listed