A Double-Masked, Randomized, Controlled Study of the Safety, Tolerability andBiological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye inPatients with Diabetic Macular Edema (DME) - DAVINCI

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Patients with clinically significant DME with central involvement defined as OCT central subfield thickness = 250 µm.
2. Adults = 18 years with type 1 or 2 diabetes mellitus with diabetic macular edema
3. ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye
4. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives; IUD; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly.
5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
6. Willingness to provide written informed consent and, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization and in other countries, as applicable according to national laws
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

1. History of vitreoretinal surgery in the study eye
2. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of Screening
3. Vision decrease due to causes other than diabetic macular edema
4. Previous use of intraocular or periocular corticosteroids in the study eye within3 months of Screening
5. Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of Screening
6. Proliferative Diabetic Retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR
7. Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either eye
8. Vitreomacular traction or epiretinal membrane in either eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision
9. Ocular inflammation (including trace or above) in the study eye
10. History of idiopathic or autoimmune uveitis in either eye
11. Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema
12. Concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period
13. Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 90 days preceding Screening
14. Aphakia or absence of the posterior capsule in the study eye
15. Uncontrolled glaucoma or previous filtration surgery in either eye. Uncontrolled glaucoma is defined as intraocular pressure greater than or equal to 25 mm Hg on an optimal medical regimen
16. Spherical equivalent of the refractive error in the study eye of more than - 8 diopters myopia (for subjects who have had refractive or cataract surgery in the study eye, preoperative spherical equivalent refractive error of more than - 8 diopters myopia)
17. Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection
18. Any ocular disorders in the study eye that, in the opinion of the Investigator, may confound interpretation of study results
19. Uncontrolled diabetes mellitus
20. Uncontrolled hypertension defined as systolic > 180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
21. History of cerebral vascular accident or myocardial infarction within 6 months prior to Day 1
22. Renal failure requiring dialysis or renal transplant
23. Participation in an investigational study within 30 days prior to Screening that involved treatment with any drug (excluding vitamins and minerals) or device
24. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk from treatment complications
25. Pregnancy or lactation
26. History of allergy to fluorescein
27. History of allergy to povidone iodine
28. Inability to obtain fundus photographs or fluorescein angiograms of sufficientquality to be analyzed by the site
29. Only one functional eye even if the eye is otherwise eligible for th

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the effect of various doses and dose intervals of intravitreally (IVT)-administered VEGF Trap-Eye on the best-corrected ETDRS visual acuity (BCVA) in subjects with DME.;Secondary Objective: 1. To assess the dose related effects of IVT adminstered VEGF Trap-Eye on foveal thickness assessed by Optical Coherence Tomography (OCT) in subjects with DME<br>2. To assess the safety and tolerability of IVT administered VEGF Trap-Eye in subjects with DME;Primary end point(s): The change in BCVA from Baseline to the Week-24 timepoint

Secondary Outcome Measures