Clinical trial NCT02034006: 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.
Official title: A 12-month, Open-label, Interventional, Multicentre Study to Investigate the Current Criteria Driving Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia
Keywords: pathological myopia
choroidal neovascularization
ranibizumab
mono-bilateral
poor visual acuity
retinal disease
eye disease
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage
timeFrame: Screening, Month 2, Month 6
measure: Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema
timeFrame: Screening, Month 2, Month 6, Month 12
measure: Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts
timeFrame: Screening, Month 2, Month 6, Month 12
measure: Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid
timeFrame: Screening, Month 2, Month 6, Month 12
measure: Change in Central Subfield Thickness (CSFT)
timeFrame: Screening, Month 2, Month 6, Month 12
measure: Change in Central Subfield Volume (CSV)
timeFrame: Screening, Month 2, Month 6, Month 12
measure: Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid
timeFrame: Screening, Month 2, Month 6, Month 12
measure: Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
measure: Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
measure: Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
measure: Number of Patients in Different Categories of Changes From Baseline in BCVA
timeFrame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
Secondary outcomes:
measure: Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye
timeFrame: Baseline, Month 6, Month 12
measure: Mean Number of Ranibizumab Injection
timeFrame: Baseline to Month 12
measure: Time to Re-treatment
timeFrame: Baseline to Month 12
measure: Number of Patients Having Ocular and/or Systemic Adverse Event (AE)
timeFrame: Baseline to Month 12
measure: Change in Patient Quality of Life From Baseline to Month 2 and Month 12
timeFrame: Baseline, Month 2, Month 12
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Novartis Investigative Site
state: AN
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Desenzano del Garda
country: Italy
facility: Novartis Investigative Site
state: BS
city: Bolzano
country: Italy
facility: Novartis Investigative Site
state: BZ
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Catanzaro
country: Italy
facility: Novartis Investigative Site
state: CZ
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: FI
city: Rapallo
country: Italy
facility: Novartis Investigative Site
state: GE
city: Terracina
country: Italy
facility: Novartis Investigative Site
state: LT
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: PA
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: PG
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: PI
city: Parma
country: Italy
facility: Novartis Investigative Site
state: PR
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Conegliano
country: Italy
facility: Novartis Investigative Site
state: TV
city: Udine
country: Italy
facility: Novartis Investigative Site
state: UD
city: Varese
country: Italy
facility: Novartis Investigative Site
state: VA
city: Negrar
country: Italy
facility: Novartis Investigative Site
state: VR
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ricci F, Staurenghi G, Varano M, Eandi C, Sinibaldi TL, Colombo L, Bartezaghi M, Bassanini S. OLIMPIC: a 12-month study on the criteria driving retreatment with ranibizumab in patients with visual impairment due to myopic choroidal neovascularization. Graefes Arch Clin Exp Ophthalmol. 2019 Apr;257(4):759-768. doi: 10.1007/s00417-019-04248-8. Epub 2019 Jan 24.