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Safety and Efficacy of IONIS-FB-Lrx in up to 120 Patients 55 and Older With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

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ClinicalTrials.gov Identifier: NCT03446144
Recruitment Status : Withdrawn (Business objective change, no safety or efficacy concerns)
First Posted : February 26, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to assess the Safety and Efficacy of IONIS-FB-Lrx for up to 120 patients with Geographic Atrophy secondary to Age Related Macular Degeneration

Condition or disease Intervention/treatment Phase
Geographic Atrophy Age Related Macular Degeneration Drug: IONIS-FB-Lrx Drug: Placebo (sterline saline 0.9%) Phase 2

Detailed Description:
This study will assess changes in complement factor B over a 69-week treatment period in a patient population 55 and older with well-demarcated Geographic Atrophy secondary to Age Related Macular Degeneration

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double Masked
Primary Purpose: Treatment
Official Title: A Phase 2, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of ISIS 696844, an Antisense Inhibitor of Complement Factor B, in Patients With Geographic Atrophy Secondary (GA) to Age-Related Macular Degeneration (AMD)
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IONIS-FB-Lrx Drug: IONIS-FB-Lrx
Single Dose of IONIS-FB-Lrx administered once weekly for weeks 1-3, and every other week or less frequently until week 70

Placebo Comparator: Placebo (sterile saline 0.9%) Drug: Placebo (sterline saline 0.9%)
Calculated volume to match active comparator. Administered subcutaneously weekly for weeks 1-3, and every other week or less frequently until week 70




Primary Outcome Measures :
  1. Efficacy of IONIS-FB-Lrx [ Time Frame: Up to 74 weeks ]
    The Efficacy of IONIS-FB-Lrx will be measured by the percent change in plasma complement factor B level


Secondary Outcome Measures :
  1. Incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx [ Time Frame: Up to 86 weeks ]
    The safety and tolerability of IONIS-FB-Lrx will be assessed by determining the incidence and severity of adverse events that are related to treatment with IONIS-FB-Lrx

  2. Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B [ Time Frame: Up to 74 weeks ]
    Proportion of patients in each treatment group achieving a >50% reduction of plasma complement factor B from Baseline to Post-Treatment

  3. Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD [ Time Frame: Up to 74 weeks ]
    Effect of IONIS-FB-Lrx on the rate of change of the area of GA secondary to AMD as measured by Fundus Autofluorescence from Baseline to Post-Treatment

  4. Effect of factor B reduction on other components of the complement pathways in AMD patients [ Time Frame: Up to 74 weeks ]
    Effect of factor B reduction on other components of the complement pathways such as AH50, CH50 and Bb in AMD patients from Baseline to Post-Treatment



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Must have given written informed consent and be able to comply with study requirements
  2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile or, if engaged in sexual relations with a female of child bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least a period of 13 weeks after the last dose of Study Drug (ISIS 696844 or placebo)
  3. Well-demarcated Geographic Atrophy due to Age Related Macular Degeneration

Key Exclusion Criteria:

  1. Clinically-significant abnormalities in medical history
  2. Diagnosis of primary or secondary immunodeficiencies of B lymphocyte function, splenectomy, glomerulonephritis or history of recurrent meningococcal disease
  3. Diabetes mellitus or thyroid disease unless well controlled for a period of at least 3 months
  4. Clinically-significant abnormalities in screening laboratory values
  5. Unwillingness to be administered, or history of a serious reaction to protocol required vaccines
  6. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
  7. History or presence of a disease other than AMD in study eye

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446144


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Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.

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Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03446144     History of Changes
Other Study ID Numbers: ISIS 696844-CS3
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ionis Pharmaceuticals, Inc.:
Geographic Atrophy
Age Related Macular Degeneration
IONIS-FB-Lrx
Complement Factor B
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Complement System Proteins
Complement Factor B
Immunologic Factors
Physiological Effects of Drugs