Status:
COMPLETED
Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
Lead Sponsor:
Philip J. Rosenfeld, MD, PhD
Collaborating Sponsors:
Alexion Pharmaceuticals, Inc.
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 sc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00935883
Start Date
July 1 2009
End Date
August 1 2013
Last Update
May 30 2017
Active Locations (1)
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1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136