Abstract
Purpose: :
To determine the influence of vitreous on efficacy of anti-VEGF therapy with ranibizumab in subfoveal CNV secondary to AMD in a retrospective analysis of the EXCITE-Study population.
Methods: :
Time-domain optical coherence tomography (TD-OCT, StratusTM OCT) of 353 patients enrolled in a phase IIIb randomized, double masked, active controlled, multicenter study comparing the efficacy and safety of ranibizumab administered in two dosing regimens (0.3 mg monthly, 0.3 mg quarterly and 0.5 mg quarterly) over 12 months were evaluated for status of vitreous (attached, foveal adhesion, detached, not visible), centerpoint-height of pigment epithelium detachment and centerpoint height of subretinal fluid at baseline and at monthly visits. Randomization to treatment arms was stratified by visual acuity score and by CNV lesion type. Data was evaluated using a mixed model analysis of variance. Analysis was bound to detect statistically significant differences of BCVA outcome between patients with attached, partially attached or detached vitreous within each treatment arm.Tests were performed to compare treatment efficacy in eyes with stable vitreous status compared to unstable vitreous status (changes from adherent to partially adherent to detached) in respect to changes of BCVA, height of pigment epithelial detachment and height of subretinal fluid.
Results: :
264 of 353 study eyes, which were equally distributed to all three treatment arms (n=89/3mg monthly, n=91/3mg quarterly, n=84/5 mg quarterly), could be observed through the full 12 months.Patients with attached vitreous or foveal adhesion of vitreous had no statistically different outcome in BCVA compared to patients with detached vitreous in all treatment arms.Change of adherent to partially adherent, or partially adherent to detached vitreous (18%) during the observational period did not influence the effectiveness of therapy (BCVA, pigment epithelial detachment and subretinal fluid in TD-OCT) compared to patients with stable status of vitreous (82%).
Conclusions: :
In the EXCITE trial anti-VEGF therapy with ranibizumab in subfoveal CNV was equally effective in patients with adherent, partially adherent or detached vitreous during a one year observational period.
Clinical Trial: :
www.clinicaltrials.gov NCT00275821
Keywords: vitreous • age-related macular degeneration • vascular endothelial growth factor