Health Condition 1: null- Choroidal Neovascularization (CNV)
Conditions
Interventions
Intervention1: Active ranibizumab: Ranibizumab treatment is administered intravitreally to the patient by the unmasked treating investigator, at the study site, based on a treatment decision made by t
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •Diagnosis of treatment naïve (patient has not received any prior medication/ treatment for the CNV lesion under study) active CNV secondary to any causes, except wAMD and PM in adults •All types of CNV lesions present in the study eye •BCVA must be between >= 24 and •Visual loss in the study eye should only be due to the presence of any eligible types of CNV based on ocular clinical, as well as FA
Exclusion criteria
Exclusion criteria: •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 •History of malignancy of any organ system within the past 5 years •History of stroke less than 6 months prior to screening •Active systemic inflammation or infection, related directly to the underlying causal disease of CNV at screening •Active diabetic retinopathy, active ocular/periocular infectious disease or active intraocular inflammation at screening •Confirmed intraocular pressure >= 25 mmHg for any reason at screening •Neovascularization of the iris or neovascular glaucoma at screening •CNV secondary to PM or wAMD •Use of any systemic anti-VEGF drugs within 6 months before baseline •History of focal laser photocoagulation with involvement of the macular area administered to treat CNV at any time •History of intraocular treatment with any anti-angiogenic drugs or verteporfin photodynamic therapy at any time •History of intravitreal treatment with corticosteroids at any time -History of vitreoretinal surgery at any time. •Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity (BCVA) change from baseline to Month 2 in study eye. The change in BCVA from baseline to Month 2Timepoint: Baseline and Month 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| BCVA change from baseline by visit up to Month 2 in study eye (ranibizumab as compared to sham treatment) The change in BCVA will be presented by each visitTimepoint: 1.Baseline, Month 2 2.(BSL, Month 1, Month 2);Change in central subfield thickness (CSFT) and central subfield volume (CSFV) in study eye from baseline over time to Month 2.CSFT and CSFV will be assessed by optical coherence tomography (OCT).Timepoint: Baseline, Month 2;Presence of active chorioretinal leakage assessed by FA at Month 2.The presence of active chorioretinal leakage will be assessed by photography imaging (i.e.FA).Timepoint: Month 2;Presence of intra-/sub-retinal fluid in study eye at Month 2.The presence of intra-/sub-retinal fluid will be assessed by OCT images.Timepoint: Baseline, Month 2 | — |
Countries
Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Latvia, Lithuania, Peru, Poland, Portugal, Republic of Korea, Russian Federation, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey
Contacts
Public ContactMurugananthan K
Head-Clinical Development
Outcome results
None listed