Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy
Intervention: Eculizumab; Saline
Intervention description: 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.; 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.
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age Related macular Degeneration; Macular Degeneration; Drusen; Geographic atrophy; Eculizumab; Soliris

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.
    

Eligibility 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