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.

NCT ID: NCT02034006

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-10
• Study Completion Date: 2016-07-15

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.

Conditions

Choroidal Neovascularization Secondary to Pathologic Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranibizumab

Patients treated with a single ranibizumab 0.5 mg/0.05ml intravitreal injection

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

All patients received a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per Committee for Human Medicinal Products (CHMP)approval. Further injections might have been required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, was evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment was allowed provided at least 14 days of intercurrence.

Interventions

Ranibizumab

All patients received a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per Committee for Human Medicinal Products (CHMP)approval. Further injections might have been required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, was evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment was allowed provided at least 14 days of intercurrence.

Intervention Type: DRUG

Other Intervention Names

RFB002

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Ancona, AN, Italy

Novartis Investigative Site

Bari, BA, Italy

Novartis Investigative Site

Bologna, BO, Italy

Novartis Investigative Site

Desenzano del Garda, BS, Italy

Novartis Investigative Site

Bolzano, BZ, Italy

Novartis Investigative Site

Cagliari, CA, Italy

Novartis Investigative Site

Catania, CT, Italy

Novartis Investigative Site

Catanzaro, CZ, Italy

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Rapallo, GE, Italy

Novartis Investigative Site

Terracina, LT, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Palermo, PA, Italy

Novartis Investigative Site

Padua, PD, Italy

Novartis Investigative Site

Padua, PD, Italy

Novartis Investigative Site

Perugia, PG, Italy

Novartis Investigative Site

Pisa, PI, Italy

Novartis Investigative Site

Parma, PR, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Siena, SI, Italy

Novartis Investigative Site

Torino, TO, Italy

Novartis Investigative Site

Conegliano, TV, Italy

Novartis Investigative Site

Udine, UD, Italy

Novartis Investigative Site

Varese, VA, Italy

Novartis Investigative Site

Negrar, VR, Italy

Novartis Investigative Site

Napoli, , Italy

Novartis Investigative Site

Napoli, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 30680452 (View on PubMed)

Other Identifiers

2013-003334-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRFB002FIT01

Identifier Type: -

Identifier Source: org_study_id