1. This study is being performed in the hope of providing a better treatment for dry age-related macular degeneration. At this time, the only recommended treatments include vitamin/micronutrient supplementation and an appropriate diet which only slow down the disease and the vision loss.


2. The drug Eculizumab (SOLIRIS) is already approved by the FDA.


3. Eculizumab is approved for a rare disease known as Paroxysmal Nocturnal Hemoglobinuria (PNH)


4. Age-Related Macular Degeneration and PNH are cause by mutations in the same pathway, and this pathway is known as the Complement Pathway.


5. The Complement Pathway is a part of your immune system.


6. Eculizumab blocks the Complement Pathway.


7. Eculizumab is very successful in treating PNH which is a fatal disease. The drug essentially stops PNH and patients with PNH have a normal quality of life.


8. Eculizumab is given as an intravenous infusion in an arm vein.


9. Eculizumab has to be given frequently.


10. The FDA-approved dosing schedule requires a dose every week for 4 weeks, then every 2 weeks thereafter.


11. In the study, patients have to come every week for 4 weeks then every 2 weeks for 6 months.


12. Half the visits are short (1-2 hours) and half the visits are long (3-4 hours).


13. Two out of three patients (67%) get the drug and one out of three patients (33%) get the placebo.


14. The doctors and nurses do not know if the patient gets the drug or the placebo and the patient doesn’t know either.


15. The drug can put a patient at risk for meningococcal meningitis, but the patient is given a vaccine at the start of the study which will protect against this infection. This infection occurs most frequently among college students and the vaccine is highly effective in preventing the infection.


16. After 6 months of therapy, the infusions are stopped and we examine patients every 3 months.


17. Patients should not participate in the study if they will be unable to come for all the visits.

For more details about the COMPLETE study, please contact the clinical study coordinator Maria Esquiabro at 305-326-6508 or at mesquiabro@med.miami.edu.