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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02034006
First received: January 9, 2014
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The primary objective of the study is to investigate current criteria driving re-treatment in patients affected by CNV secondary to PM and experiencing a relapse of the disease after the first administration of ranibizumab.


Condition Intervention Phase
Choroidal Neovascularization Secondary to Pathologic Myopia
Drug: Ranibizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Describe current criteria driving re-treatment in patients experiencing a relapse after first ranibizumab injection [ Time Frame: Baseline to month 12 ] [ Designated as safety issue: No ]

    The primary objective of the study is to investigate current criteria driving re-treatment in patients affected by CNV secondary to PM and experiencing a relapse of the disease after the first administration of ranibizumab. The criteria for re-treatment may consist in patient subjectivity or a clinical decision (described through clinical examination, BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Descriptive statistic on the FAS population will be provided.

    The proportion of patients who need re-treatment will be displayed together with a 95% confidence interval. The criteria for re-treatment will be summarized, presenting, for each, frequencies, percentages and 95% CI.



Secondary Outcome Measures:
  • Visual acuity changes [ Time Frame: baseline, month 6, month 12 ] [ Designated as safety issue: No ]
    To evaluate the mean changes in BCVA at 6M and 12M versus baseline. Summary statistics for BCVA will be provided for values at baseline and at each assessment and for changes versus baseline at each assessment. Results will be reported overall and separately for the sub-group of patients who need vs. not the re-treatment. A paired test of BCVA at 6 and 12 months vs. baseline will be also provided on all patients. An exploratory analysis of BCVA changes by class of disease duration, gender, age at entry, diopters and relevant medical conditions will be also provided.

  • mean number of ranibizumab injection [ Time Frame: baseline to month 12 ] [ Designated as safety issue: No ]
    To evaluate the mean number of ranibizumab injections by patient/year. The number and percentage of patients who need re-treatment will be provided.

  • time to relapse / retratment [ Time Frame: baseline to month 12 ] [ Designated as safety issue: No ]

    Time to re-treatment, defined as time in days from the data of first dose of ranibizumab to the date of re-treatment, will be evaluated. Descriptive statistics will be provided. A Kaplan-Meier curve will also be shown.

    The relationship between patient baseline characteristics and the need for re-treatment will be explored by means of logistic regression analysis


  • Number and percentage of patients having ocular or systemic adverse events [ Time Frame: baseline to month 12 ] [ Designated as safety issue: Yes ]

    AEs will be summarized as following: n° and % of patients having any AE, an ocular AE, a non-ocular AE, an AE in each primary system organ class, or with at least one serious ocular or non-ocular AE.

    Summary tables will be presented: overall and by gender, for the subset of AEs suspected to be treatment related.

    Deaths, SAEs, and AEs leading to discontinuation of investigational treatment will be listed separately and, if appropriate, summarized by primary system organ class and preferred term.

    IOP, vital signs measurements and laboratory data, where available, will be summarized with descriptive statistics of actual values and changes from baseline values. Summary tables will be presented overall and by gender.

    The incidence rates of notable vital sign abnormalities will be also provided.


  • Evaluation of patient quality of life [ Time Frame: baseline, month 2, month 12 ] [ Designated as safety issue: No ]

    To evaluate changes in the quality of life after ranibizumab injection, by means of IVI Questionnaire, a 32-item questionnaire developed to measure the impact of vision impairment on daily activities in five domains. Domain scores and total score will be summarized descriptively in actual values and changes versus baseline at each assessment.

    The Burden of Illness and Health Resources Utilization questionnaire will also be used ro gain information on resource consumption and burden for the patient and relatives to the disease. Summary statistic will be provided for each item.



Estimated Enrollment: 150
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab
patients treated with ranibizumab 0,5 mg/0,05ml intravitreal injection
Drug: Ranibizumab
All patients will receive a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per CHMP approval. Further injections might be required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, will be evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment is allowed provided at least 14 days of intercurrence.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034006

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Italy
Novartis Investigative Site Not yet recruiting
Casale Monferrato, AL, Italy, 15033
Novartis Investigative Site Not yet recruiting
Ancona, AN, Italy, 60126
Novartis Investigative Site Not yet recruiting
Bari, BA, Italy, 70124
Novartis Investigative Site Not yet recruiting
Bologna, BO, Italy, 40138
Novartis Investigative Site Not yet recruiting
Desenzano del Garda, BS, Italy, 25015
Novartis Investigative Site Not yet recruiting
Bolzano, BZ, Italy, 39100
Novartis Investigative Site Not yet recruiting
Cagliari, CA, Italy, 09124
Novartis Investigative Site Not yet recruiting
Chieti, CH, Italy, 66100
Novartis Investigative Site Not yet recruiting
San Feramo della Battaglia, CO, Italy, 22020
Novartis Investigative Site Not yet recruiting
Catania, CT, Italy, 95123
Novartis Investigative Site Not yet recruiting
Catanzaro, CZ, Italy, 88100
Novartis Investigative Site Recruiting
Firenze, FI, Italy, 50134
Novartis Investigative Site Not yet recruiting
Genova, GE, Italy, 16132
Novartis Investigative Site Not yet recruiting
Rapallo, GE, Italy, 16035
Novartis Investigative Site Not yet recruiting
Terracina, LT, Italy, 04019
Novartis Investigative Site Not yet recruiting
Milano, MI, Italy, 20132
Novartis Investigative Site Not yet recruiting
Milano, MI, Italy, 20122
Novartis Investigative Site Not yet recruiting
Milano, MI, Italy, 20157
Novartis Investigative Site Not yet recruiting
Palermo, PA, Italy, 90127
Novartis Investigative Site Not yet recruiting
Padova, PD, Italy, 35128
Novartis Investigative Site Not yet recruiting
Padova, PD, Italy, 35100
Novartis Investigative Site Not yet recruiting
Perugia, PG, Italy, 06100
Novartis Investigative Site Recruiting
Pisa, PI, Italy, 56124
Novartis Investigative Site Not yet recruiting
Parma, PR, Italy, 43100
Novartis Investigative Site Not yet recruiting
Roma, RM, Italy, 00161
Novartis Investigative Site Not yet recruiting
Roma, RM, Italy, 00144
Novartis Investigative Site Not yet recruiting
Roma, RM, Italy, 00133
Novartis Investigative Site Not yet recruiting
Roma, RM, Italy, 00198
Novartis Investigative Site Recruiting
Siena, SI, Italy, 53100
Novartis Investigative Site Not yet recruiting
Torino, TO, Italy, 10122
Novartis Investigative Site Not yet recruiting
Trieste, TS, Italy, 34129
Novartis Investigative Site Not yet recruiting
Conegliano, TV, Italy, 31015
Novartis Investigative Site Not yet recruiting
Udine, UD, Italy, 33100
Novartis Investigative Site Not yet recruiting
Varese, VA, Italy, 21100
Novartis Investigative Site Not yet recruiting
Negrar, VR, Italy, 37024
Novartis Investigative Site Not yet recruiting
Napoli, Italy, 80131
Novartis Investigative Site Not yet recruiting
Napoli, Italy, 80138
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02034006     History of Changes
Other Study ID Numbers: CRFB002FIT01
Study First Received: January 9, 2014
Last Updated: July 8, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Novartis:
pathological myopia
choroidal neovascularization
ranibizumab
mono-bilateral
poor visual acuity
retinal disease
eye disease
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

Additional relevant MeSH terms:
Choroidal Neovascularization
Myopia
Neoplasm Metastasis
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Neoplasms
Neoplastic Processes
Pathologic Processes
Refractive Errors
Uveal Diseases
Angiogenesis Modulating Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014