Clinical Trial: Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Vas

Brief Summary: This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2 [ Time Frame: Baseline, Month 2 ]

Original Primary Outcome: Best-corrected visual acuity (BCVA) change from baseline to Month 2 in study eye [ Time Frame: Baseline and Month 2 ]

Current Secondary Outcome:

• 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. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. 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 was assessed 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: Baseline, 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 of Intra-retinal Fluid in Study Eye Compared to Baseline [ Time Frame: Baseline, Month 2, Month 6, Month 12 ]
  The presence of intra-retinal fluid was assessed by OCT.
• Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline [ Time Frame: Baseline, Month 2, Month 6, Month 12 ]
  Presence of subretinal fluid in study eye compared to baseline
• Number of Participants With Presence of Active Chorioretinal Leakage [ Time Frame: Baseline, Month 2, Month 6, Month 12 ]
  The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).
• 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. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). 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 Requirement for 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.
• Number of Participants With Ranibizumab Treatments in Study Eye [ 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 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: Month 12 ]
  The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.

Original Secondary Outcome:

• 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-/sub-retinal 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 chorioretinal leakage assessed by FA at Month 2 [ Time Frame: Month 2 ]
  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 ]
  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 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 ]
  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 ]
  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 ]
  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 ]
  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 ]
  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 ]

Dates:
Date Received: April 23, 2013
Date Started: September 2013
Date Completion:
Last Updated: August 15, 2016
Last Verified: August 2016