To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

This study is currently recruiting participants.
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01846299
First received: April 30, 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 macular edema (ME).


Condition Intervention Phase
Macular Edema (ME)
Other: Sham control
Drug: Ranibizumab
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 Intravtitreal Injections in Patients With Visual Impairment Due to VEGF-driven Macular Edema

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-/subretinal 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 ME leakage assessed by fluorescein angiography (FA) at Month 2 [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    The presence of active ME leakage will be assessed by photography imaging (i.e., FA).

  • Requirement for rescue treatment at Month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
  • 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 ME leakage in study eye at Month 2, Month 6, and Mon th 12 compared to Baseline [ Time Frame: Baseline, Month 2, Month 6, Month 12 ] [ Designated as safety issue: No ]
    The presence of active ME leakage will be assessed by photographic images (i.e. Fluorescein angiography).

  • Proportion of patients with ≥ 1, ≥ 5, ≥ 10 and ≥ 15 letters gain or reaching 84 letters, 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.

  • Porportion 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, 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 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, laboratory results if reported as an adverse event (AE) will be presented.


Estimated Enrollment: 187
Study Start Date: October 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 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 followp 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/0.5mL 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 ME lesion under study) active ME secondary to any causes (for adult patients: except DME and RVO);
  • BCVA must be between ≥ 24 and ≤ 83 letters tested at 4 meters starting distance using ETDRS-like visual acuity charts;
  • Visual loss should be only due to the presence of any eligible types of ME based on ocular clinical, as well as FA and OCT findings.

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 ME at screening;
  • Active diabetic retinopathy, active ocular/periocular infectious disease or active intraocular inflammation at screening;
  • Confirmed intraocular pressure (IOP) ≥ 25 mmHg for any reason at screening;
  • Neovascularization of the iris or neovascular glaucoma at screening;
  • ME secondary to DME or RVO (for adult patients only);
  • Use of any systemic anti-VEGF drugs within 6 months before baseline;
  • History of focal/grid laser photocoagulation with involvement of the macular area administered to treat ME at any time;
  • History of intraocular treatment with any anti-angiogenic drugs (including any anti-VEGF agents) or verteporfin photodynamic therapy (vPDT) 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: NCT01846299

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 91 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: NCT01846299     History of Changes
Other Study ID Numbers: CRFB002G2302, 2012-005418-20
Study First Received: April 30, 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:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014