Visual impairment due to neovascular AMD MedDRA version: 19.0 Level: LLT Classification code 10060837 Term: Choroidal neovascularization System Organ Class: 100000004853
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patient: 1. Male or female patients, = 18 years of age. 2. Written informed consent must be obtained before any study-related assessment is performed. Inclusion criteria for study eye: 3. Visual impairment predominantly due to neovascular AMD. 4. Active, newly diagnosed, untreated, angiographically documented, CNV lesion (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub-RPE fluid on OCT) secondary to neovascular AMD in line with SmPC of ranibizumab (Lucentis®) and aflibercept (Eylea®). 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: Exclusion criteria for systemic medical history and conditions: 1. Any type of systemic disease or its treatment, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. 2. Stroke or myocardial infarction less than 3 months prior to screening. 3. Presence of uncontrolled systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at the time of screening or baseline. 4. Type 1 or Type 2 diabetes mellitus according to ADA (2014) and/or WHO (2006) classifications (see Appendix 2, Table A2-2) with glycosylated hemoglobin (HbA1c) > 10% (> 86 mmol/mol) at screening. Diabetic patients should be on diet, exercise and/or pharmacological treatment for diabetes, which must have been stable for at least 3 months. 5. Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures or to fluorescein or any other component of fluorescein formulation. Exclusion criteria for ocular medical history and conditions For either eye: 6. Any active periocular or ocular infection or inflammation at the time of screening or baseline 7. Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication or according to investigator’s judgment) at the time of screening or baseline. 8. Neovascularization of the iris or neovascular glaucoma at the time of screening or baseline. For study eye: 9. Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline. 10. Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wAMD (e.g., ocular histoplasmosis, pathologic myopia) at the time of screening or baseline. 11. Irreversible structural damage within 0.5 disc diameter of the center of the macula (e.g., vitreomacular traction, epiretinal membrane, scar, laser burn, macular hole) at the time of screening or baseline that in the investigator’s opinion could preclude visual function improvement with treatment. For fellow eye: 12. Retinal or choroidal neovascularization or macula edema requiring treatment of any cause at the time of screening or baseline or the anticipation of development of the above mentioned medical conditions requiring treatment within 3 months past screening or baseline. Exclusion criteria for prior or current systemic medication: 13. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives from screening, whichever is longer. 14. Use of any systemic anti-VEGF drugs (e.g., bevacizumab [Avastin®], ziv-aflibercept [Zaltrap®]). 15. Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening. 16. Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil®), tamoxifen, phenothiazines and ethambutol. Exclusion criteria for prior or current ocular treatment For study eye: 17. Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept as measured by the area under the curve (AUC) from baseline to study week 12.;Secondary Objective: The secondary objectives of this study are as follows: - To compare systemic VEGF-A protein levels in patients switching from monthly 2 mg aflibercept injections to monthly 0.5 mg ranibizumab compared to patients treated with monthly 0.5 mg ranibizumab from baseline as measured by the AUC from study week 12 to week 24. - To explore whether systemic VEGF-A levels of patients switching from aflibercept to ranibizumab will adjust to levels comparable to baseline or to levels comparable as in patients treated from baseline with ranibizumab from study week 12, over time up to week 24.;Primary end point(s): Comparison of systemic VEGF-A protein levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept as measured by the area under the curve (AUC).;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison of systemic VEGF-A protein levels in patients switching from monthly 2 mg aflibercept injections to monthly 0.5 mg ranibizumab compared to patients treated with monthly 0.5 mg ranibizumab from baseline as measured by the AUC from study week 12 to week 24. Exploration whether systemic VEGF-A levels of patients switching from aflibercept to ranibizumab will adjust to levels comparable to baseline or to levels comparable as in patients treated from baseline with ranibizumab from study week 12, over time up to week 24.;Timepoint(s) of evaluation of this end point: week 24 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice (MCC)
Novartis Pharma GmbH
Outcome results
None listed