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Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD) (COMPLETE)

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ClinicalTrials.gov Identifier: NCT00935883
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : January 26, 2015
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Philip J. Rosenfeld, MD, PhD, University of Miami

Tracking Information
First Submitted Date  ICMJE July 7, 2009
First Posted Date  ICMJE July 9, 2009
Results First Submitted Date  ICMJE December 4, 2014
Results First Posted Date  ICMJE January 26, 2015
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE July 2009
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • Growth of Geographic Atrophy [ Time Frame: 6 months ]
  • Decrease in Drusen Volume [ Time Frame: 6 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
Growth of geographic atrophy/Change in drusen volume [ Time Frame: 6 months/12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2017)
  • Change in Visual Acuity for Drusen Group [ Time Frame: Baseline/ 6 Months ]
    Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart.
  • Change in Visual Acuity for Geographic Atrophy Group [ Time Frame: Baseline/ 6 Months ]
    Visual function was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning. Maximum score would be 100 letters read and minimum would be count fingers, hand motion and light perception if there were no letters read on the chart.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
Change in visual acuity [ Time Frame: 6 months/12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
Official Title  ICMJE Eculizumab for the Treatment of Non-Exudative Age-Related Macular Degeneration: An Exploratory Study to Evaluate the Effects of C5 Inhibition on Drusen and Geographic Atrophy
Brief Summary To evaluate the safety and efficacy of eculizumab for the treatment of dry AMD as evaluated by the change in drusen volume and area of geographic atrophy.
Detailed Description

This is a randomized, double-arm, double-masked study designed to evaluate the safety and efficacy of eculizumab for the treatment of patients with dry AMD. There are three stages in the study: the screening period, the treatment period, and the follow-up period.During the screening period patients will be evaluated for eligibility. Eligible patients will receive either eculizumab or placebo for 24 weeks.

A total of 60 patients will be enrolled and divided equally between the drusen cohort and the GA cohort. A 2:1 randomization will result in 20 patients in each cohort receiving eculizumab while 10 patients receive placebo.

The treatment period will begin two weeks after administration of the meningococcal vaccine. During the treatment period, patients will receive eculizumab or placebo over a period of approximately 26 weeks. Patient will treatment according to the following regimen:

Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).

Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days).

After the final scheduled dose of eculizumab or Placebo at week 24, patients will return for follow-up exam 2 weeks, 3 months, and 6 months after the final dose.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: Eculizumab

    Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).

    Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.

    Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months.

    Other Name: Soliris
  • Drug: Saline

    Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).

    Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.

    Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months.

    Other Name: PBS
Study Arms  ICMJE
  • Placebo Comparator: Saline
    Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
    Intervention: Drug: Saline
  • Active Comparator: Eculizumab
    Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
    Intervention: Drug: Eculizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 50 years
  • In the study eye(s), the presence of non-exudative AMD documented by fundus photography, autofluorescence, fluorescein angiography, and spectral domain OCT.
  • Visual acuity of 20/63 or better (BCVA score of at least 59 letters) as measured on an ETDRS chart.
  • Able and willing to comply with study procedures.

Exclusion Criteria:

  • Visual acuity worse than 20/63
  • Any history of choroidal neovascularization in the study eye
  • Unresolved meningococcal disease.
  • Confounding ocular conditions such as amblyopia; aphakia; myopia requiring >6 diopters of correction; pigment epithelial detachment; uncontrolled glaucoma (intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication); steroid-induced ocular hypertension; retinal inflammatory disease; central serous choroidopathy; prior or current retinal detachment; macular edema; cystic lesion (individual cysts or cystoid macular edema); ocular herpes simplex virus; severe non-proliferative or worse diabetic retinopathy; anterior ischemic optic neuropathy; RPE tear involving the macula; pseudovitelliform macular degeneration; vitreo-retinal traction maculopathy; vitreous hemorrhage, history of or current rhegmatogenous retinal detachment or macular hole; uveitis; diffuse choroidal atrophy; optic atrophy (as evidenced by pallor); intraocular inflammation; ocular or periocular infection; moderate or worse dry eye syndrome; clinically significant cataract or opacification of the posterior capsule which, in the Investigator's opinion, would progress during the course of the study and could affect central vision; other ocular conditions that the Investigator believes may be a confounding factor in this study
  • Refusal to be vaccinated against Neisseria meningitides or an active Neisseria meningitides infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00935883
Other Study ID Numbers  ICMJE 20090055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philip J. Rosenfeld, MD, PhD, University of Miami
Study Sponsor  ICMJE Philip J. Rosenfeld, MD, PhD
Collaborators  ICMJE Alexion Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Philip J Rosenfeld, MD, PhD University of Miami
PRS Account University of Miami
Verification Date April 2017

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