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

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:
NCT01846299
First received: April 30, 2013
Last updated: July 30, 2014
Last verified: July 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 as needed.
Drug: Ranibizumab
Ranibizumab 0.5mg/0.5mL is administered intravitreally to the patient
Sham Comparator: sham control
Sham injection is given to the study eye as needed
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.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of active ME secondary to any causes;
  • BCVA must be between ≥ 24 and ≤ 83 letters;
  • Visual loss should be mainly due to the presence of any eligible types of ME.

Exclusion Criteria:

  • Women of child-bearing potential,
  • Active malignancies;
  • History of stroke less than 6 months prior to screening;
  • Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
  • Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
  • Any type of advanced, severe or unstable ocular disease or its reatment;
  • ME with a high likelihood of spontaneous resolution.

Other protocol-defined inclusion/exclusion criteria may apply.

  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: NCT01846299

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 92 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: July 30, 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 September 16, 2014