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

This study has been completed.
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Philip J. Rosenfeld, MD, PhD, University of Miami
ClinicalTrials.gov Identifier:
NCT00935883
First received: July 7, 2009
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Age-Related Macular Degeneration
Drug: Eculizumab
Drug: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Growth of geographic atrophy/Change in drusen volume [ Time Frame: 6 months/12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in visual acuity [ Time Frame: 6 months/12 months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: July 2009
Study Completion Date: August 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator
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
Active Comparator: Eculizumab
Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935883

Locations
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
Philip J. Rosenfeld, MD, PhD
Alexion Pharmaceuticals
Investigators
Principal Investigator: Philip J Rosenfeld, MD, PhD University of Miami
  More Information

No publications provided by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philip J. Rosenfeld, MD, PhD, Professor of Ophthalmology, University of Miami
ClinicalTrials.gov Identifier: NCT00935883     History of Changes
Other Study ID Numbers: 20090055
Study First Received: July 7, 2009
Last Updated: August 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
Age Related macular Degeneration
Macular Degeneration
Drusen
Geographic atrophy
Eculizumab
Soliris

Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014