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Efficacy of ranibizumab combined with photodynamic therapy on wet age-related macular degeneration.

ABSTRACT: Efficacy and safety of intravitreal ranibizumab (IVR) combined with photodynamic therapy (PDT) in treating wet age-related macular degeneration (wAMD) were studied. A total of 130 eyes were collected from 130 wAMD patients treated in Affiliated to Qingdao University Yuhuangding Hospital of Yantai, of which 65 were given IVR combined with PDT (combination therapy group) and the remaining 65 were treated with simple IVR (ranibizumab group). The differences in best corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure, choroidal neovascularization (CNV) leakage, levels of serum vascular endothelial growth factor (VEGF) and transforming growth factor-?1 (TGF-?1) as well as complication rate were compared before and after treatment between the two groups. At 1, 3, 6 and 12 months after treatment, combination therapy group had remarkably better BCVA and notably smaller CMT than ranibizumab group. Fundus fluorescein angiography (FFA) showed that the area of macular degeneration was reduced markedly after treatment in both groups, and the area in combination therapy group was evidently smaller than that in ranibizumab group at 1, 3 and 6 months after treatment. At 3 months after treatment, the levels of serum VEGF and TGF-?1 declined obviously in the two groups compared with those before treatment. The IVR combined with PDT can effectively improve the visual acuity, decrease CMT and prominently reduce the area of macular degeneration of wAMD patients, and its therapeutic effects are long-standing and tolerable for the patients, so it is worthy of clinical popularization.

SUBMITTER: Chen L

PROVIDER: S-EPMC7185075 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Efficacy of ranibizumab combined with photodynamic therapy on wet age-related macular degeneration.

Chen Ling L Wang Bing B Cui Wei W Fang Shufen S

Experimental and therapeutic medicine 20200402 6

Efficacy and safety of intravitreal ranibizumab (IVR) combined with photodynamic therapy (PDT) in treating wet age-related macular degeneration (wAMD) were studied. A total of 130 eyes were collected from 130 wAMD patients treated in Affiliated to Qingdao University Yuhuangding Hospital of Yantai, of which 65 were given IVR combined with PDT (combination therapy group) and the remaining 65 were treated with simple IVR (ranibizumab group). The differences in best corrected visual acuity (BCVA), c ...[more]

PMID: 32346433

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Project description:BackgroundRazumab™ (world's first biosimilar ranibizumab) is approved for several macular disorders including wet age-related macular degeneration (AMD). We evaluated the safety and efficacy of biosimilar ranibizumab in wet AMD.MethodsThis prospective, multicentre, rAnibizumab bioSimilar Safety Efficacy postmarkeTing (ASSET) study enrolled patients aged ≥ 50 years with wet AMD having best-corrected visual acuity (BCVA) between 20/40 and 20/320. The patients received intravitreal biosimilar ranibizumab 0.5 mg every 4 weeks for 24 weeks. Safety endpoints included the incidence of adverse events (AEs), serious AEs (SAEs), and immunoreactivity after 6 months. The efficacy endpoints were the proportion of patients who lose fewer than 15 letters, increase in BCVA, change in central retinal thickness (CRT), and change in Visual Function Questionnaire-25 (VFQ-25) score, from baseline to 24 weeks.ResultsOf the 126 enrolled patients, majority (95.24%) of the patients received all 6 doses of biosimilar ranibizumab (total 3 mg). Nineteen AEs were reported (n = 16; 12.7%); majority (78.9%) were mild. There were no serious AEs reported, except one AE of death which was unrelated to the study drug. None of the patients discontinued the study due to an AE. The most common ocular AE was increase in intraocular pressure (4 events) and non-ocular AE was pyrexia (5 events). A total of 7.9% (10/126) patients prior to dosing and 7.1% (9/126) patients post-treatment were positive for anti-ranibizumab antibodies. No AEs suggestive of immunogenicity were noted. At 24-weeks, 97.60% patients in the intent-to-treat (ITT) population (N = 125) and 97.41% patients in the per-protocol (PP) population (N = 116) lost < 15 letters from baseline visual acuity. In the ITT and PP populations, 31.20% and 32.76% patients, respectively, showed improved visual acuity by ≥ 15 letters. Significant improvements in BCVA (mean difference: 8.8, 9.2, p < 0.001 for ITT, PP) and VFQ-25 (8.5, 9.2, p < 0.001 for ITT, PP) were seen; CRT reduced significantly (125 µm, 119.3 µm, p < 0.001 for ITT, PP).ConclusionRazumab™ (world's first biosimilar ranibizumab) was well-tolerated without new safety concerns and significantly improved visual acuity in wet AMD patients. Trial registration CTRI/2016/03/006739. Registered 18 March 2016-Prospectively registered, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13141&EncHid=&userName=2016/03/006739.

Project description:BackgroundClinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data.MethodsIn a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a noninferiority limit of 5 letters on the eye chart.ResultsBevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern.ConclusionsAt 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.).

Dataset Information

Efficacy of ranibizumab combined with photodynamic therapy on wet age-related macular degeneration.

Publications

Efficacy of ranibizumab combined with photodynamic therapy on wet age-related macular degeneration.

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