Objective: To compare treatment outcomes of ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy in participants with PCV for 24 months.
Design, Setting, and Participants: This 24-month, phase IV, double-masked, multicenter, randomized clinical trial (EVEREST II) was conducted among Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography.
Interventions: Participants (N = 322) were randomized 1:1 to ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n = 168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy group; n = 154). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT (combination group) or sham PDT (monotherapy group) on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions.
Main Outcomes and Measures: Evaluation of combination therapy vs monotherapy at 24 months in key clinical outcomes, treatment exposure, and safety. Polypoidal lesion regression was defined as the absence of indocyanine green hyperfluorescence of polypoidal lesions.
Results: Among 322 participants (mean [SD] age, 68.1 [8.8] years; 225 [69.9%] male), the adjusted mean best-corrected visual acuity (BCVA) gains at month 24 were 9.6 letters in the combination therapy group and 5.5 letters in the monotherapy group (mean difference, 4.1 letters; 95% CI, 1.0-7.2 letters; P = .005), demonstrating that combination therapy was superior to monotherapy by the BCVA change from baseline to month 24. Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P
METHODS: Twenty patients with periodontitis were recruited for the trial. Following random allocation of either quadrants of the selected jaw to test or control treatment, conventional non-surgical periodontal therapy (NSPT) was performed. In addition, the test side received adjunct photodynamic therapy. Probing depth (PD), clinical attachment level, bleeding on probing (BoP) and plaque scores (PS%) were recorded at phase 0 (baseline), phase 1 (immediately after NSPT), phase 2 (7 days following NSPT), phase 3 (1 month following NSPT) and phase 4 (3 months following NSPT). Subgingival plaque samples for quantification of Aa by real-time polymerase chain reaction was performed at phases 0, 1, 2 and 4.
RESULTS: There was a significant clinical improvement at phases 3 and 4 compared with baseline while BoP reduced significantly only in the test group at phase 4. However, no difference in the quantification of Aa was detected between the groups.
CONCLUSIONS: Within the limits of the study, PDT adjunct to scaling and root planing does not lead to quantitative reduction of Aa in periodontitis patients.