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

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-074-13
• Date of registration: 14/04/2014
• Prospective Registration: No
• Primary sponsor: NOVARTIS BIOSCIENSES PERU S.A.,
• Public title: ASSESS THE EFFICACY/SAFETY OF INTRAVITREAL RANIBIZUMAB IN PEOPLE WITH VISION LOSS DUE TO CHOROIDAL NEOVASCULARIZATION
• Scientific title: 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)
• Date of first enrolment: 03/02/2014
• Target sample size: 4
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=074-13
• Study type: Interventional
• Study design: This is a phase III, randomized, double-masked, sham-controlled,; multicenter study in adult patients, with a non-randomized, open-label group of; adolescent patients. At Month 2, all adult patients assigned to the sham group will; switch to the ranibizumab treatment group, while all adolescent patients will receive; open-label ranibizumab treatment as of baseline.
• Phase: III

Countries of recruitment

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

• Name: Oscar La Torre Barrenechea
• Affiliation: NOVARTIS BIOSCIENCES PERU S.A.

• Name: Juan Lopez Reyes
• Affiliation: NOVARTIS BIOSCIENCES PERU S.A.

Key inclusion & exclusion 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:
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


Age minimum: 18
Age maximum: 99
Gender: Both

Health Condition(s) or Problem(s) studied

-H31

H31

Intervention(s)

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, and sham.
• Ranibizumab - 0.5 mg/0.05 mL vial
This document (090095a88481ad5b in docbase CREDI_BS) has been digitally signed with external signatures using Entrust PKI.
Signatures manifested as of 4/8/2013 1:37:10 PM, signing status at this time: Completed (1 of 1 signatures)
Approved for report publication by Borrello Mary in East Hanover at Mon, 08 Apr 2013 09:36:30 AM EDT
Novartis Confidential Page 12
Clinical Trial Protocol Protocol No. CRFB002G2301
• Sham - consists of an empty vial (adult patients only)

Source(s) of Monetary Support

NOVARTIS BIOSCIENSES PERU S.A.

Ethics review

Status: Approved
Approval date: 31/07/2013
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 13/01/2014
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]