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Change in drusen volume as a novel clinical trial endpoint for the study of complement inhibition in age-related macular degeneration.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Filho, Carlos Alexandre De Amorim Garcia Yehoshua, Zohar Gregori, Giovanni Nunes, Renata Portella Penha, Fernando Marcondes Zhang, Kang Feuer, William J. |
| Copyright Year | 2014 |
| Abstract | BACKGROUND AND OBJECTIVE To evaluate the change in drusen volume following treatment with eculizumab, a systemic inhibitor of complement component 5. PATIENTS AND METHODS Single-center, prospective, randomized, double-masked clinical trial. Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 26 weeks. MAIN OUTCOME MEASURE decrease in drusen volume of at least 50% at 26-week follow-up. RESULTS Mean drusen cube root volumes were 0.49 mm and 0.47 mm (P = .64) at baseline and 0.51 mm and 0.42 mm (P = .17) at 26 weeks in the eculizumab and placebo groups, respectively. In the placebo group, one eye had a decrease in drusen volume of at least 50% and two eyes developed neovascularization through 26 weeks. CONCLUSION Systemic complement inhibition with eculizumab did not significantly reduce drusen volume. Drusen growth was dependent on the number of complement at-risk alleles. Future trials should consider the use of a composite clinical trial endpoint in which efficacy is defined by the treatment’s ability to prevent drusen growth, neovascularization, and the formation of geographic atrophy over 1 year. |
| Starting Page | 18 |
| Ending Page | 31 |
| Page Count | 14 |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | https://www.healio.com/ophthalmology/journals/osli/2014-1-45-1/%7Baeaacbed-2768-4ad9-8634-dc60cc81fb5e%7D/change-in-drusen-volume-as-a-novel-clinical-trial-endpoint-for-the-study-of-complement-inhibition-in-age-related-macular-degeneration.pdf |
| Alternate Webpage(s) | http://www.healio.com/ophthalmology/journals/osli/2014-1-45-1/%7Baeaacbed-2768-4ad9-8634-dc60cc81fb5e%7D/change-in-drusen-volume-as-a-novel-clinical-trial-endpoint-for-the-study-of-complement-inhibition-in-age-related-macular-degeneration.pdf |
| PubMed reference number | 24354307v1 |
| Volume Number | 45 |
| Issue Number | 1 |
| Journal | Ophthalmic surgery, lasers & imaging retina |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Age related macular degeneration Blinded Complement System Proteins Drusen Eye Geographic Atrophy Pathologic Neovascularization Patients eculizumab |
| Content Type | Text |
| Resource Type | Article |
