E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic Macular Edema (DME) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 2. To assess the safety and tolerability of IVT administered VEGF Trap-Eye in subjects with DME |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Microperimetry Sub-Study: Sites that are equipped with the Nidek MP-1 will perform microperimetry at Screening (V1), Day 1 (V2), Week 4 (V4), Week 12 (V6), Week 24 (V9), Week 36 (V12) and Week 52 (V16). It is estimated that approximately 10 subjects per group will participate in this sub-study. Purpose: Microperimetry can be used to enhance the quantification of visual function of the macula apart from Best Corrected Visual Acuity. It is hypothesized that subjects treated with VEGF Trap-Eye will require fewer laser treatments than the control group and there will be a measurable difference by microperimetry in the function of the macula.
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E.3 | Principal 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 |
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E.4 | Principal 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 the study 30. Other ocular conditions with poorer prognosis in the fellow eye |
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E.5 End points |
E.5.1 | Primary end point(s) |
The change in BCVA from Baseline to the Week-24 timepoint |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |