Choroidal neovascularization not related to wet Age-related macular degeneration (wAMD), pathologic myopia (PM)or Pseudoxanthoma elasticum (PXE), as well as in Macular Edema (ME) not related to Retinal Vein Occlusion (RVO) or Diabetic macular edema (DME) and other ocular neovascularization and/or complication such as Rubeosis Iridis and Neovacular Glaucoma and Proliferative Diabetic Retinopathy requiring Vitrectomy MedDRA version: 18.0 Level: HLGT Classification code 10047060 Term: Retina, chor
Conditions
Sponsors
Novartis Pharma S.A.S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients (= 18 years old) Patient with diagnosis of: •Active choroidal neovascularization (CNV) secondary to any causes (except wAMD, PM and PXE), involving the center of the fovea, confirmed by complete ocular examination of the study eye •Active macular edema (ME) confirmed by complete ocular examination of the study eye, secondary to any causes: oExcluding DME and RVO. oIncluding non infectious uveitis, non responder or with contraindication to dexamethasone (Ozurdex®) according to investigator’s judgment •Rubeosis iridis/neovascular glaucoma. •Proliferative diabetic retinopathy requiring vitrectomy. •Visual loss should only be due to the presence of any eligible type of CNV or to any eligible ME or to RI/NVG or to PDR/V based on ocular clinical, as well as FA and OCT and/or ICGA findings. And/or •Diagnosis of disease activity is based on investigator judgment: •CNV: presence of posterior pole changes compatible with active CNV (e.g. sub- or intraretinal fluid, hemorrhage), seen by fundus ophthalmoscopy, biomicroscopy and fundus photography; presence of active leakage from CNV seen by fluorescein angiography (FA) and/or ICGA; presence of intra- or subretinal fluid/hemorrhage seen by optical coherence tomography (OCT) •ME: presence of posterior pole changes compatible with active ME (e.g. sub-retinal fluid), seen by fundus ophthalmoscopy, biomicroscopy and fundus photography; presence of active leakage from ME seen by fluorescein angiography (FA); presence of intra-retinal fluid/cysts seen by optical coherence tomography (OCT). •Rubeosis iridis, NVG: surface neovascularization extension = stade 1 of “Teich and Walsh grading system” seen by slit lamp examination 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: •< 18 years of age •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. •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 ß HCG laboratory test •History of hypersensitivity to ranibizumab •Use of other investigational drugs within 30 days or 5 half-lives from Baseline, whichever is longer. •Use of any systemic anti-angiogenic drugs 3 months before inclusion •CNV secondary to PM, wAMD or PXE •ME secondary to DME or RVO •Posterior segment inflammation secondary to non infectious uveitis that might benefit from dexamethasone (Ozurdex®) according to investigator judgment •History of intraocular treatment with any anti-angiogenic drugs (including any anti-VEGF agents) or corticosteroids within 2 months before inclusion •Active or suspected ocular infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the 2-year safety of ranibizumab as assessed by type, rate and severity of serious and non-serious, ocular and non-ocular adverse events. ;Secondary Objective: •To describe ranibizumab efficacy at 3 months as assessed by suitable endpoint for each disease category over all monthly post-baseline assessments from Month 1 to Month 3: oBest-corrected visual acuity change (BVCA) for diseases affecting the macular area either through Choroidal neovascularization (CNV) or Macular edema (ME) oChange of the extent of iris neovascularization using “Teich and Walsh grading system” using iris photography for Rubeosis Iridis (RI) and Neovacular Glaucoma (NVG) oOccurrence of postoperative vitreous cavity hemorrhage for Proliferative Diabetic Retinopathy requiring Vitrectomy (RDP/V).;Primary end point(s): •Adverse events, serious and non-serious, ocular and non-ocular;Timepoint(s) of evaluation of this end point: at 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •ranibizumab efficacy at 3 months as assessed by suitable endpoint for each disease category over all monthly post-baseline assessments from Month 1 to Month 3: oBCVA change for diseases affecting the macular area either through CNV or ME oChange of the extent of iris neovascularization using “Teich and Walsh grading system” using iris photography for NVG/RI •To describe 6, 12, 24 months ranibizumab efficacy as assessed by the suitable endpoint over all monthly post-baseline assessments from Month 1 to Month 6, 12, 24. •To analyze efficacy results taking into account patient profile, demographic characteristics, past and current medical history, prior treatment, and severity of disease. •To describe relevant anatomical parameters (retinal thickness, fluid leakage, …) change over time (Months 3, 6, 12, 24) •To describe patient management: yearly average number of ranibizumab injections, reasons for retreatment, use of other treatments and yearly average number of follow-up visits. oOccurrence of postoperative vitreous cavity hemorrhage for PDR/V ;Timepoint(s) of evaluation of this end point: at month 3, 6, 12, 24 | — |
Countries
France
Contacts
Public ContactInformation&Communication Médicales
Novartis Pharma S.A.S
Outcome results
None listed