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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age-Related Macular Degeneration
Interventions Drug: Eculizumab
Drug: Saline
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saline Eculizumab
Hide Arm/Group Description

Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator

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.

Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab

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.

Period Title: Treatment Period
Started 20 40
Completed 19 38
Not Completed 1 2
Reason Not Completed
Physician Decision             1             0
Withdrawal by Subject             0             2
Period Title: Follow-Up Period
Started 19 38
Completed 19 38
Not Completed 0 0
Arm/Group Title Saline Eculizumab Total
Hide Arm/Group Description

Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator

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.

Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab

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.

Total of all reporting groups
Overall Number of Baseline Participants 20 40 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  15.0%
6
  15.0%
9
  15.0%
>=65 years
17
  85.0%
34
  85.0%
51
  85.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 40 participants 60 participants
75.7  (8.64) 75.1  (8.0) 75.3  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
Female
10
  50.0%
19
  47.5%
29
  48.3%
Male
10
  50.0%
21
  52.5%
31
  51.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 40 participants 60 participants
20 40 60
1.Primary Outcome
Title Growth of Geographic Atrophy
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab
Arm/Group Title Saline Eculizumab
Hide Arm/Group Description:

Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator

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.

Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab

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.

Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: millimeters
0.18  (0.15) 0.19  (0.12)
2.Primary Outcome
Title Decrease in Drusen Volume
Hide Description [Not Specified]
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab
Arm/Group Title Saline Eculizumab
Hide Arm/Group Description:

Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator

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.

Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab

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.

Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: mm^3
0.12  (0.08) 0.15  (0.17)
3.Secondary Outcome
Title Change in Visual Acuity for Drusen Group
Hide Description 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.
Time Frame Baseline/ 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Drusen Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab
Arm/Group Title Saline Eculizumab
Hide Arm/Group Description:

Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator

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.

Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab

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.

Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: letters
4.0  (7.0) 2.4  (3.9)
4.Secondary Outcome
Title Change in Visual Acuity for Geographic Atrophy Group
Hide Description 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.
Time Frame Baseline/ 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Geographic Atrophy Cohort included 10 eyes randomized to saline and 20 eyes randomized to Eculizumab
Arm/Group Title Saline Eculizumab
Hide Arm/Group Description:

Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator

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.

Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab

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.

Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: letters
-2.6  (7.2) 2.5  (4.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Eculizumab
Hide Arm/Group Description

Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator

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.

Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab

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.

All-Cause Mortality
Saline Eculizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Saline Eculizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Eculizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/40 (0.00%)    
Cardiac disorders     
chest pains   1/20 (5.00%)  1 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Philip J Rosenfeld
Organization: University of Miami Miller School of Medicine
Phone: 305-326-6148
EMail: prosenfeld@med.miami.edu
Layout table for additonal information
Responsible Party: Philip J. Rosenfeld, MD, PhD, University of Miami
ClinicalTrials.gov Identifier: NCT00935883    
Other Study ID Numbers: 20090055
First Submitted: July 7, 2009
First Posted: July 9, 2009
Results First Submitted: December 4, 2014
Results First Posted: January 26, 2015
Last Update Posted: May 30, 2017