A 12-month study to evaluate the efficacy and safety of injections of 0.5 mg ranibizumab into the eye of patients with impaired vision which is caused by new vessels (neovascularization) in the choroid and for which ranibizumab may have a positive impact

Phase 1

• Conditions: Visual impairment due to vascular endothelial growth factor (VEGF) driven choroidal neovascularization (CNV); MedDRA version: 17.0Level: LLTClassification code 10060837Term: Choroidal neovascularizationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-005417-38-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-26
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• Diagnosis of active CNV secondary to any causes (for adult patients: except wAMD, PCV or PM), with the CNV or its sequelae affecting the fovea, confirmed by at least one of the three following criteria:
a) Presence of posterior pole changes compatible with active CNV seen by fundus ophthalmoscopy and/or biomicroscopy
b) Presence of leakage from CNV seen by fluorescein angiography (FA)
c) Presence of intra- or subretinal fluid seen by optical coherence tomography (OCT)
• At least one of the following CNV lesion types present in the study eye:
a) Subfoveal (presence of abnormal neovasculature in the avascular central fovea)
b) Juxtafoveal (presence of abnormal neovasculature not under the center of the fovea but within 200 µm from the center) with involvement of the central macular area
c) Extrafoveal (presence of abnormal neovasculature more than 200 µm from the center of the fovea) with involvement of the central macular area
d) Margin of the optic disc (presence of abnormal neovasculature at peripapillary area) with involvement of the central macular area
• BCVA must be between = 24 and = 83 letters tested at 4 meters starting distance using ETDRS-like visual acuity charts (approximate Snellen chart equivalents of 20/25 and 20/320) in the study eye
• Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV (for adult patients: non-wAMD and non-PM) based on ocular clinical, as well as FA and/or OCT findings

Are the trial subjects under 18? yes
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 157
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

For both eyes
• Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation (e.g., anterior chamber cells (ACC) >2+ and/or vitreous haze (VH) >2+). Rescreening is permitted after intra-ocular inflammation is successfully treated with antiinflammatory therapy that does not compromise eligibility
• Confirmed intraocular pressure (IOP) = 25 mmHg for any reason
• Neovascularization of the iris or neovascular glaucoma
• Inability to obtain fundus photographs, fluorescein angiograms or OCT images of sufficient quality to be analyzed
For study eye
• CNV secondary to wAMD, PCV or PM (for adult patients only). RAP lesions are exclusionary in patients 50 years of age or older.
• 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 preretinal membrane of the macula)
• Any type of ocular advanced, severe or unstable disease or its treatment that could interfere with the primary and/or secondary outcome evaluations.
• CNV- conditions with a high likelihood of spontaneous resolution (e.g., CNV due to choroidal rupture), unless deemed chronic by the Investigator (e.g., lasting for > 2 months or being recurrent).History of laser photocoagulation with involvement of the macular area at any time

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified