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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01846299
First received: April 30, 2013
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections 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 Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in BCVA in Study Eye up to Month 2 [ Time Frame: Baseline, Month 1, Month 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The presence of subretinal fluid was assessed by OCT.

  • Number of Participants With Presence of Active Macular Edema (ME) Leakage [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.


Enrollment: 181
Study Start Date: October 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ranibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
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.
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.

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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

  Show 61 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01846299     History of Changes
Other Study ID Numbers: CRFB002G2302  2012-005418-20 
Study First Received: April 30, 2013
Results First Received: February 29, 2016
Last Updated: April 14, 2016
Health Authority: European Union: European Medicines Agency

Keywords provided by Novartis:
Vision Impairment

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Endothelial Growth Factors
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 26, 2016