Clinical Trial: Atacicept in Subjects With Optic Neuritis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Co

Brief Summary: This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

Detailed Summary:
Sponsor: EMD Serono

Current Primary Outcome: Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV) [ Time Frame: Baseline, LOV (Week 48) ]

Original Primary Outcome: Change of RNFL thickness assessed by OCT. [ Time Frame: up to 48 weeks ]

Current Secondary Outcome:

• Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye [ Time Frame: Weeks 12, 24 and 36 ]
  The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.
• Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24 [ Time Frame: Baseline, Weeks 12 and 24 ]
  The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.
• Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 [ Time Frame: Baseline, Weeks 12, 24 and 36 ]
  The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.
• Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36 [ Time Frame: Baseline, Weeks 12, 24 and 36 ]
  The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.
• Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36 [ Time Frame: Baseline, Weeks 12, 24 and 36 ]
  The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.
• Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified [ Time Frame: Weeks 12, 24 and 36 ]
  Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.
• Contrast Sensitivity: Total Number of Letters Correctly Identified [ Time Frame: Weeks 12, 24 and 36 ]
  Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.
• Contrast Sensitivity: Score Line [ Time Frame: Weeks 12, 24 and 36 ]
  Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).
• Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack [ Time Frame: From baseline (Study Day 1) up to Week 36 ]
  Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature [axillary, orally or intraauricularly] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported.

Original Secondary Outcome: Measures of RNFL integrity and visual function [ Time Frame: weeks 12, 24, 36 ]

Information By: EMD Serono

Dates:
Date Received: February 15, 2008
Date Started: June 2008
Date Completion:
Last Updated: January 19, 2016
Last Verified: January 2016