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ASSESS THE EFFICACY/SAFETY OF INTRAVITREAL RANIBIZUMAB IN PEOPLE WITH VISION LOSS DUE TO CHOROIDAL NEOVASCULARIZATION

A 12-MONTH, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 0.5 MG RANIBIZUMAB INTRAVITREAL INJECTIONS IN PATIENTS WITH VISUAL IMPAIRMENT DUE TO VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF) DRIVEN CHOROIDAL NEOVASCULARIZATION (CNV)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-074-13
Enrollment
4
Registered
2014-04-14
Start date
2014-02-03
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Investigational and reference therapy: The investigational treatment used in this study is 0.5 mg ranibizumab, based on individual patient needs, applied as an intravitreal injection of 0.05 mL,

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of treatment naïve, active CNV secondary to any causes (for adult patients: except wAMD and PM), confirmed by complete ocular examination in the study eye using the following criteria: • Presence of posterior pole changes compatible with active CNV (e.g. subor intra-retinal fluid, hemorrhage), seen by fundus ophthalmoscopy, biomicroscopy and fundus photography • Presence of active leakage from CNV seen by fluorescein angiography (FA) • Presence of intra- or subretinal fluid/hemorrhage seen by optical coherence tomography (OCT) • At least one of the following lesion types present in the study eye: • Subfoveal (presence of abnormal neovasculature in the avascular central fovea)

Exclusion criteria

Exclusion criteria: For both eyes • Active diabetic retinopathy, active ocular/periocular infectious disease or active intra-ocular inflammation at screening • Confirmed intraocular pressure (IOP) ≥ 25 mmHg for any reason at screening • Neovascularization of the iris or neovascular glaucoma at screening • Inability to obtain fundus photographs, fluorescein angiograms or OCT images of sufficient quality to be analyzed • For study eye • Ocular disorders that could confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period, including retinal detachment, cataract (if causing significant visual impairment), macular hole and pre-retinal membrane of the macula • CNV secondary to PM or wAMD (for adult patients only) • 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 (including any anti-VEGF agents) or verteporfin photodynamic therapy (vPDT) at any time • History of intravitreal treatment with corticosteroids at any time • History of vitreoretinal surgery at any time

Countries

Albania, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Hungary, India, Italy, Korea North, Korea South, Latvia, Poland, Portugal, Russian Federation, Slovakia, Spain, Switzerland

Contacts

Public ContactOscar Barrenechea

NOVARTIS BIOSCIENCES PERU S.A.

oscar.barrenechea@novartis.com2006400 anex 6512

Outcome results

None listed

Source: REPEC (via WHO ICTRP)