Abstract
Purpose: :
CNTF2 is a double-masked, 1-year multicenter trial to evaluate the effect of sustained intraocular delivery of CNTF by encapsulated cell technology implant in patients with decreased visual acuity associated with atrophic non-neovascular AMD. Herein, we determined changes in retinal thickness, as determined by OCT, in this trial.
Methods: :
51 patients were randomized to receive a high CNTF-secreting implant, a low-CNTF-secreting implant, or sham surgery in a 2:1:1 ratio in one eye. Stratus OCT scans were obtained with the fast macular thickness protocol on both eyes of patients at baseline, and 4, 6 and 12 months post implant. Quantitative thickness measurements and morphological parameters were evaluated. Data were available for interim analysis at baseline, 4, and 6 months.
Results: :
There was significantly increased total macular volume (TMV) when compared to baseline, at 4 (p<0.001) and 6 months (p=0.01) in the high-releasing group, and at 4 months (p=0.003) in the low-releasing group compared to the sham group. Furthermore, although there was no difference in study eye and fellow eye TMV at baseline, the difference in TMV in the study eye relative to the fellow eye was significantly greater in the high- and low-releasing groups compared to the sham group at 4 and 6 months (P<0.02). There were no significant differences in the change in center point thickness or central 1 mm subfield thickness at 4 or 6 months for the study eye relative to baseline, or when compared to the fellow eye. The proportion of eyes with CME increased during the study, but there was no difference in proportion of eyes with CME among the different treatment groups.
Conclusions: :
In this interim analysis, CNTF was associated with increased retinal thickness, when compared to sham, in eyes with advanced atrophic dry AMD. Together with the morphological data, the results suggest a biological effect related to increased cell number and/or increased cell volume. The 12 month analysis will be presented, and will indicate whether the observed effects persist beyond 6 months.
Clinical Trial: :
www.clinicaltrials.gov NCT00447954
Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials