Phase 2
N=60
Complement Inhibition With Eculizumab for the Treatment of Non-Exudative Macular Degeneration (AMD)
Age-Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00935883 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Growth of Geographic Atrophy — 0.18; 0.19 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eculizumab (Drug); Saline (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Philip J. Rosenfeld, MD, PhD
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Growth of Geographic Atrophy |
0.18; 0.19 | — |
| PRIMARY Decrease in Drusen Volume |
0.12; 0.15 | — |
| SECONDARY Change in Visual Acuity for Drusen Group |
4.0; 2.4 | — |
| SECONDARY Change in Visual Acuity for Geographic Atrophy Group |
-2.6; 2.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT00935883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.