Abstract
Purpose: :
To compare: 1) Outcomes of 0.5 vs.2.0 mg ranibizumab injections (RI) for serous vascularized pigment epithelial detachment (SVPED) vs. fibrovascular pigment epithelial detachment (FVPED), and 2) Vision results for eyes with vs. without flattening of pigment epithelial detachment (PED) due to AMD.
Methods: :
For this prospective, randomized trial the RI groups were: 1) 0.5 mg monthly (QM) x12 months (M), 2) 0.5 mg QM x 4 M followed by PRN injections to 12 M, 3) 2.0 mg QM x12 M, 4) 2.0 mg QM x 4 M followed by PRN injections to 12 M. Primary outcome measures were pre- and post-RI (last visit), best corrected standardized vision (BCVA). Secondary outcome measures were pre- and post central-1mm thickness (1mm); area (A2), greatest diameter (GLD), and heights of PED and choroidal neovascularization (CNV); subretinal fluid (SRF), cystoid macular edema (CME); adverse events. An exploratory analysis compared the outcomes of eyes classified as SVPED (Grp1) vs. FVPED (Grp 2). Vision results were also compared for eyes with vs. without resolved PED. Statistical analyses were 2 and 3-way analysis of variance (ANOVA), Wilcoxon Signed Rank, Mann-Whitney, and Chi-Square tests.
Results: :
For the 36 eyes (26 women), 8 were in Grp1 and 28 in Gp2. The mean age was 78.6 years, and mean follow-up was 9.0 M. There were no differences in all baseline features between groups except PEDA2 (Grp2 > Grp1). Two-way ANOVA (pre/post, lesion type) showed significant reduction in post-RI PED height, PED and CNV A2 and GLD, 1mm , SRF, CME, and improved BCVA compared to baseline (all p<0.03). There were no differences in all variables between groups, except for slightly greater PED SA2 and GLD in Grp2 compared to Grp 1 eyes (p<0.05). Three-way ANOVA (pre/post, lesion type, dose) showed no differences in all variables, irrespective of dose (all p>0.05). There was a trend for greater PED flattening in Grp1 eyes, but statistical significance was not reached (87.5% in Grp 1 [95% CI: 64.5%-100%]), 53.6% in Grp 2 [95% CI: 35.1%-72.1%], p =0.08). A similar proportion of retinochoroidal anastomosis (RAP) lesions were found in both groups (12.5% in Grp 1 [95% CI: 0-35.4%] and 17.9% in Grp 2 [95% CI: 3.7%-32.1%], p=0.72). There was no difference in cataract worsening between groups. RPE tears were in 2 Grp 1 eyes and 3 Grp 2 eyes. Improved vision was more frequent in eyes with than without resolved PED (p=0.03).
Conclusions: :
The outcome and safety profiles appeared to be similar for eyes with SVPED and FVPED, irrespective of the 2 doses of ranibizumab. Flattening of PED was associated with greater frequency of vision improvement.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00749021
Keywords: vascular endothelial growth factor • retinal pigment epithelium • age-related macular degeneration