Assess the Efficacy/Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Choroidal Neovascularization

This study is currently recruiting participants.
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01840410
First received: April 23, 2013
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

To evaluate the efficacy and safety of 0.5 mg in adult patients with visual impairment due to choridal neovascularization (CNV).


Condition Intervention Phase
Choroidal Neovascularization (CNV)
Drug: Ranibizumab
Other: Sham control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to VEGF-driven Choroidal Neovascularization

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Best-corrected visual acuity (BCVA) change from baseline to Month 2 in study eye [ Time Frame: Baseline and Month 2 ] [ Designated as safety issue: No ]
    The change in BCVA from baseline to Month 2


Secondary Outcome Measures:
  • BCVA change from baseline by visit up to Month 2 in study eye (ranibizumab as compared to sham treatment) [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: No ]
    The change in BCVA will be presented by each visit (BSL, Month 1, Month 2)

  • Change in central subfield thickness (CSFT) and central subfield volume (CSFV) in study eye from baseline over time to Month 2 [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: No ]
    CSFT and CSFV will be assessed by optical coherence tomography (OCT).

  • Presence of intra-/sub-retinal fluid in study eye at Month 2 [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: No ]
    The presence of intra-/sub-retinal fluid will be assessed by OCT images.

  • Presence of active chorioretinal leakage assessed by FA at Month 2 [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    The presence of active chorioretinal leakage will be assessed by photography imaging (i.e.FA).

  • Average BCVA change in study eye from baseline to Month 1 through Month 12 [ Time Frame: Baseline, Month 1, Month 6, Month 12 ] [ Designated as safety issue: No ]
    All monthly BCVA outcomes compared to the BCVA at baseline.

  • Change from baseline in CSFT and CSFV in study eye by visit [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ]
    The change in CSFT and CSFV will be assessed monthly by OCT

  • Presence of intra-/subretinal fluid in study eye at Month 2, Month 6 and Month 12 compared to Baseline [ Time Frame: Baseline, Month 2, Month 6, Month 12 ] [ Designated as safety issue: No ]
    The presence of intra-/sub-retinal fluid will be assessed by OCT

  • Presence of active chorioretinal leakage in study eye at Month 2, Month 6 and Month 12 compared to Baseline [ Time Frame: Baseline, Month 2, Month 6, Month 12 ] [ Designated as safety issue: No ]
    The presence of active chorioretinal leakage will be assessed by photographic images (i.e., FA).

  • Proportion of patients with ≥ 1, ≥ 5, ≥ 10 and ≥ 15 letters gain or reaching 84 letters in study eye, at Month 2, Month 6 and Month 12 [ Time Frame: Month 2, Month 6, Month 12 ] [ Designated as safety issue: No ]
    This outcome measure represents the proportion of different levels of BCVA gain

  • Proportion of patients with > 1, > 5, > 10 and > 15 letters loss at Month 2, Month 6 and Month 12 [ Time Frame: Month 2, Month 6, Month 12 ] [ Designated as safety issue: No ]
    This outcome measure represents the proportion of different levels of BCVA loss.

  • Number of ranibizumab treatments and re-treatments to study eye by Month 2, Month 6 and Month 12 [ Time Frame: Month 2, Month 6, Month 12 ] [ Designated as safety issue: No ]
    Total number of injections and number of injections given to the study eye by visit

  • Type, frequency and severity of ocular and non-ocular adverse events in the study eye up to Month 2, up to Month 6 and up to Month 12 [ Time Frame: Month 2, Month 6, Month 12 ] [ Designated as safety issue: Yes ]
    Safety parameters will include reports of both ocular and non-ocular adverse events (AEs). Safety findings resulting from ophthalmic examinations, vital signs, and laboratory results if reported as an adverse event (AE) will be presented.

  • Requirement for rescue treatment at Month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 187
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active ranibizumab
A 0.5 mg ranibizumab intravitreal injection will be given to the study eye at baseline followed by further administration of ranibizumab as needed at the follow-up study visits, based on evidence of disease activity assessed at each individual visit and as judged by the clinical investigator.
Drug: Ranibizumab
Ranibizumab treatment is administered intravitreally to the patient by the unmasked treating investigator, at the study site, based on a treatment decision made by the masked evaluating investigator. Ranibizumab 0.5mg intravitreal injection will be provided as investigational treatment (ranibizumab for intravitreal injection vial in the concentration of 10mg/mL corresponding to a 0.5 mg dose level).
Sham Comparator: sham control
Sham injection is given at baseline, followed by an individualized treatment regimen based on evidence of disease activity assessed at each individual visit as judged and assessed by the investigator. At Month 2, all adult patients randomized into the sham arm will be switched to open-label treatment with ranibizumab, where individualized treatment continues, based on evidence of disease activity.
Other: Sham control
The sham vial will not contain active drug (empty sterile vial). The sham injection is an imitation of an intravitreal injection using an injection syringe without a needle touching the eye. The sham is administered to the patient by the unmasked treating investigator, at the study site, based on a treatment decision made by the masked evaluating investigator.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of treatment naïve (patient has not received any prior medication/ treatment for the CNV lesion under study) active CNV secondary to any causes, except wAMD and PM in adults
  • All types of CNV lesions present in the study eye
  • BCVA must be between ≥ 24 and ≤ 83 letters in the study eye tested at 4 meters starting distance using ETDRS like visual acuity charts
  • Visual loss in the study eye should only be due to the presence of any eligible types of CNV based on ocular clinical, as well as FA

Exclusion Criteria:

  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
  • History of malignancy of any organ system within the past 5 years
  • History of stroke less than 6 months prior to screening
  • Active systemic inflammation or infection, related directly to the underlying causal disease of CNV at screening
  • Active diabetic retinopathy, active ocular/periocular infectious disease or active intraocular inflammation at screening
  • Confirmed intraocular pressure ≥ 25 mmHg for any reason at screening
  • Neovascularization of the iris or neovascular glaucoma at screening
  • CNV secondary to PM or wAMD
  • Use of any systemic anti-VEGF drugs within 6 months before baseline
  • History of focal laser photocoagulation with involvement of the macular area administered to treat CNV at any time
  • History of intraocular treatment with any anti-angiogenic drugs or verteporfin photodynamic therapy at any time
  • History of intravitreal treatment with corticosteroids at any time -History of vitreoretinal surgery at any time.
  • Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840410

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 84 Study Locations
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: NCT01840410     History of Changes
Other Study ID Numbers: CRFB002G2301, 2012-005417-38
Study First Received: April 23, 2013
Last Updated: January 17, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Novartis:
Vision Impairment
Abnormal growth of blood vessels

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 21, 2014