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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01846299
First Posted: May 3, 2013
Last Update Posted: May 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
April 30, 2013
May 3, 2013
February 29, 2016
May 23, 2016
May 23, 2016
October 2013
September 2015   (Final data collection date for primary outcome measure)
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye [ Time Frame: Baseline, Month 2 ]
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Best-corrected visual acuity (BCVA) change from baseline to Month 2 in study eye [ Time Frame: Baseline and Month 2 ]
The change in BCVA from baseline to Month 2
Complete list of historical versions of study NCT01846299 on ClinicalTrials.gov Archive Site
  • Change From Baseline in BCVA in Study Eye up to Month 2 [ Time Frame: Baseline, Month 1, Month 2 ]
    BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
  • Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye [ Time Frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]
    CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
  • Change From Baseline in Central Subfield Volume (CSFV) in Study Eye [ Time Frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ]
    CSFV was assessed OCT. A negative change from baseline indicates improvement.
  • Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline [ Time Frame: Month 2, Month 6, Month 12 ]
    The presence of intra-retinal fluid was assessed by OCT.
  • Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline [ Time Frame: Month 2, Month 6, Month 12 ]
    The presence of subretinal fluid was assessed by OCT.
  • Number of Participants With Presence of Active Macular Edema (ME) Leakage [ Time Frame: Month 2 ]
    The presence of active ME leakage was assessed by fluorescein angiography (FA).
  • Number of Participants Requiring Rescue Treatment at Month 1 [ Time Frame: Month 1 ]
    Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.
  • Average Change From Baseline in BCVA [ Time Frame: Baseline (BL), month 1 through month 6, month 1 through month 12 ]
    BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
  • Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters [ Time Frame: Month 2, Month 6 , Month 12 ]
    VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
  • Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss [ Time Frame: Month 2, Month 6, Month 12 ]
    VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
  • Number of Participants With Ranibizumab Treatments [ Time Frame: Month 12 ]
    The number of participants administered study treatments, according to treatment frequency, was assessed.
  • Number of Participants With Re-treatments [ Time Frame: Month 6, month 12 ]
    The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to Month 12, the maximum number of retreatments was 5.
  • Number of Primary Reasons for Decision to Treat by Investigator [ Time Frame: 12 months ]
    The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
  • BCVA change from baseline by visit up to Month 2 in study eye (ranibizumab as compared to sham treatment) [ Time Frame: Baseline, Month 2 ]
    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 ]
    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 ]
    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 ]
    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 ]
  • Average BCVA change in study eye from baseline to Month 1 through Month 12 [ Time Frame: Baseline, Month 1, Month 6, Month 12 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Not Provided
Not Provided
 
To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema
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 Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Macular Edema (ME)
  • Other: Sham control
    The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
  • Drug: Ranibizumab
    Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
  • Experimental: Ranibizumab
    A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
    Intervention: Drug: Ranibizumab
  • Sham Comparator: Sham control
    Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
    Intervention: Other: Sham control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
September 2015
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
  • 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.

Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Netherlands,   Russian Federation,   Singapore,   Slovakia,   Spain,   Switzerland,   Turkey,   United Kingdom
Ireland,   South Africa
 
NCT01846299
CRFB002G2302
2012-005418-20 ( EudraCT Number )
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP