gms | German Medical Science

102. Jahrestagung der DOG

Deutsche Ophthalmologische Gesellschaft e. V.

23. bis 26.09.2004, Berlin

Durability of Lucentis™ therapy in exudative AMD

Meeting Abstract

  • corresponding author S. Michels - Bascom Palmer Eye Institute, University of Miami, USA
  • J. Lee - Bascom Palmer Eye Institute, University of Miami, USA
  • C. Puliafito - Bascom Palmer Eye Institute, University of Miami, USA
  • P.J. Rosenfeld - Bascom Palmer Eye Institute, University of Miami, USA

Evidenzbasierte Medizin - Anspruch und Wirklichkeit. 102. Jahrestagung der Deutschen Ophthalmologischen Gesellschaft. Berlin, 23.-26.09.2004. Düsseldorf, Köln: German Medical Science; 2004. Doc04dogFR.04.13

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dog2004/04dog200.shtml

Veröffentlicht: 22. September 2004

© 2004 Michels et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Objective

In Phase I/II studies, intravitreal injections of Lucentis™ (ranibizumab) resulted in inhibition of choroidal neovascularization (CNV) and resolution of macular edema, subretinal fluid, and RPE detachments with improvement of visual acuity in most patients. We investigated the durability of this treatment effect in patients who had completed the injection phase of Lucentis™clinical studies.

Methods

We studied 23 eyes of patients enrolled in open-label Phase I/II studies investigating multiple intravitreal injections of Lucentis™. All subjects had complete resolution of macular edema, subretinal fluid, and RPE detachments with no significant growth of CNV. Patients were followed monthly after their final injection and underwent ETDRS visual acuity testing, ophthalmologic examination, fluorescein angiography (FA), and macular optical coherence tomography (OCT) imaging. Patients were considered for re-injection if at least 5 letters of visual acuity were lost in association with leakage from recurrent CNV or if there was an increase of at least 100μ in central retinal thickness by OCT or if there was evidence of new classic CNV by FA or subretinal hemorrhage by fundus examination.

Results

During a one year follow-up, 7of 23 eyes had no evidence of recurrent CNV and did not require re-injection. During this time, the median visual acuity decreased by 3 letters when compared with the visual acuity at the end of the Phase I/II injection phase. Of the 16 eyes re-injected due to recurrent CNV, the median visual acuity decreased by 6.5 letters at the time of re-injection, and the median time to re-injection was 196 days. All 16 eyes had an increase in central retinal thickness by OCT with a median increase of 104μ. Among these 16 eyes, 12 eyes were re-injected because the vision decreased by at least 5 letters. All 12 eyes had leakage from CNV as determined by OCT, and 10 eyes had leakage as determined by FA. Leakage was not detected by FA in 2 eyes. Among the 4 patients without vision loss who were re-injected, 3 were re-injected because of an increase in central macular thickness of at least 100µm, and one was re-injected because of a new subretinal hemorrhage. At the end of one year, the re-injected patients had an overall median vision loss of only 3 letters compared with baseline.

Conclusions

Lucentis™ therapy can result in a durable treatment benefit lasting at least one year after the completion of an injection cycle. The majority of patients who developed recurrent CNV and received re-injection required additional therapy after 6 months. Further studies are required to optimize the durability of this treatment benefit; however these results suggest that OCT imaging combined with visual acuity testing and ophthalmic examination may be sufficient to detect recurrent CNV and the need for re-injection.