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

NCT00935883 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-05-30

Study results available
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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.

Conditions

  • Age-Related Macular Degeneration

Interventions

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.

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.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Philip J. Rosenfeld, MD, PhD

    lead OTHER

Principal Investigators

  • Philip J Rosenfeld, MD, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-06-30
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00935883 on ClinicalTrials.gov