A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia. (OLIMPIC)

Novartis

Status and phase

Completed

Phase 3

Conditions

Choroidal Neovascularization Secondary to Pathologic Myopia

Treatments

Drug: Ranibizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02034006

CRFB002FIT01

2013-003334-33 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study was to investigate current criteria driving re-treatment in patients affected by Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM) and experiencing a relapse of the disease after the first administration of ranibizumab.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent given before any study related procedure is performed
Diagnosis of active CNV secondary to PM confirmed by complete ocular examination in the affected eye(s) using the following criteria:
Presence of high myopia greater than -6D of spherical equivalence
Presence of posterior changes compatible with pathologic myopia (any signs of attenuation of retinal pigment epithelium (RPE) and choroids, mottling of the RPE, tilted disc, geographic atrophy of RPE, Fuchs spots, posterior staphyloma, submacular hemorrhage, lacquer cracks) detected by fundus ophthalmoscopy and fundus photography
Presence of active leakage from CNV observed through fluorescein angiography (FAG)
Presence of intra or subretinal fluid demonstrated by Optical Coherence Tomography (OCT)
BCVA > 24 letters and < 78 letters tested at 4 meters staring distance using ETDRS-like visual acuity chart
Visual loss must be only due to the presence of any eligible types of CNV related to PM based on clinical ocular findings, FAG and OCT. (Also patients that have for example 20/60 as their best visual acuity due to PM in their history and have additional vision loss due to CNV lesion can be included)

Exclusion criteria

Patients with inability to comply with study related procedures
Pregnant or nursing (lactating) women and women of childbearing potential UNLESS using effective contraception during treatment
Presence of confirmed systolic blood pressure > 150 mmHg or diastolic > 90 mmHg at the time of enrollment
History of stroke
Any type of advanced, severe or unstable medical condition or its treatment that could significantly bias the assessment of clinical status and interfere with primary and/or secondary outcome evaluations or put the patient at risk
Presence of active infectious disease or intra-ocular inflammation in either eye at the time of enrollment
Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period (including retinal detachment, cataract and pre-retinal membrane of the macula)
History of pan-retinal or focal/grid laser photocoagulation with involvement of the macular area in the study eye at any time
History of intraocular treatment with any anti-vascular endothelial growth factor (VEGF), verteporfin photodynamic therapy (vPDT) and any intra-ocular surgery or corticosteroid administration within one month before study entrance
Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation
Simultaneous participation in a study that includes administration of any investigational drug