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Treatment patterns of ranibizumab intravitreal injection and dexamethasone intravitreal implant for retinal vein occlusion in the USA.

ABSTRACT: PurposeRanibizumab, an anti-vascular endothelial growth factor, and dexamethasone, a corticosteroid, have been shown to be effective in treating macular oedema secondary to retinal vein occlusion (RVO) (central RVO (CRVO) and branch RVO (BRVO)). Their real-world usage, however, has yet to be compared. We therefore evaluated ophthalmology visits for both drugs using US patient-level data.MethodsThe IMS Health Real-World Data Medical Claims database was used to identify treatment-naive patients receiving ranibizumab intravitreal injections or dexamethasone intravitreal implants between June 2010 and February 2014 who had 12 months of follow-up data. The primary outcome measure was the mean number of all ophthalmology visits for the two drugs in patients with CRVO and BRVO. Secondary outcome measures included a comparison of treatment visits, non-treatment visits, and time intervals between visits.ResultsOverall, 2822 patients received ranibizumab injections (CRVO, 1178; BRVO, 1644) and 365 received dexamethasone implants (CRVO, 191; BRVO, 174). The mean number (SD) of all ophthalmology visits was higher for patients receiving ranibizumab injections than for those receiving dexamethasone implants (CRVO: 7.2 (3.6) vs 6.2 (3.1), P<0.001; BRVO: 7.1 (3.4) vs 6.3 (3.1), P=0.016).ConclusionsPatients with RVO receiving ranibizumab injections had a mean of approximately one more visit to their ophthalmologist in the first 12 months of treatment than those treated with dexamethasone implants. The visit burden is therefore not substantially different and physicians should focus on the clinical benefits of these drugs when evaluating treatment options for RVO.

SUBMITTER: Nghiem-Buffet S

PROVIDER: S-EPMC5395996 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Treatment patterns of ranibizumab intravitreal injection and dexamethasone intravitreal implant for retinal vein occlusion in the USA.

Nghiem-Buffet S S Baillif S S Regnier S S Skelly A A Yu N N Sodi A A

Eye (London, England) 20161202 4

PurposeRanibizumab, an anti-vascular endothelial growth factor, and dexamethasone, a corticosteroid, have been shown to be effective in treating macular oedema secondary to retinal vein occlusion (RVO) (central RVO (CRVO) and branch RVO (BRVO)). Their real-world usage, however, has yet to be compared. We therefore evaluated ophthalmology visits for both drugs using US patient-level data.MethodsThe IMS Health Real-World Data Medical Claims database was used to identify treatment-naive patients re ...[more]

PMID: 27911446

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Project description:Purpose:To evaluate retinal functional improvement by means of visual acuity and retinal sensibility examination after intravitreal dexamethasone implant in patients affected by cystoid macular edema secondary to retinal vein occlusion. Methods:Twenty-six consecutive patients affected by retinal vein occlusion complicated by cystoid macular edema were enrolled in this prospective interventional study. All patients underwent a baseline complete ophthalmological evaluation as well as retinal angiography, OCT examination, and microperimetry evaluation. Each patient was treated with intravitreal injection of a long-term steroid implant (Ozurdex, Allergan). Follow-up evaluations were performed at months 1, 3, and 6 and completed by OCT and MP1 examination. Clinical data underwent statistical analysis. Results:Baseline functional evaluation showed mean visual acuity of 0,63±0,42 LogMAR and retinal sensitivity of 7,93±4,73?dB (mean±standard deviation); after treatment, at day 30 we found, respectively, 0,43±0,38 LogMAR (p<0.05, compared to baseline) and 10,15±4,410?dB (p<0.05); at day 90, we found 0,44±0,32 (p<0.05) and 9.61±4,29?dB (p<0.05); at day 180, we found 0,41±0,31 (p<0.05) and 9,95±3,79?dB (p<0.05). Fixation pattern improved significantly (p<0.05), showing a stable fixation in 30% of patients at baseline, increasing to 77% of patients at day 180. Baseline morphological evaluation showed a central retinal thickness (CRT) of 398,21±181,65??m after treatment; we found a CRT of 222,64±95,21??m at day 30 (p<0.05, compared to baseline), 307,50±120,25??m (p<0.05) at day 90, and 294,93±135,86??m (p<0.05) at day 180. About 15,3% patients showed already at month 3 a recurrence of macular edema. They underwent a retreatment before month 6 as for treatment guidelines. Conclusion:Our detailed analysis showed the significative increase in retinal function in the early phases of the follow-up. Retinal sensibility showed a stronger correlation than VA in macular edema reabsorption, better underlying the progressive functional recovery and increase in quality of vision and life for the patients. This trial is registered with ClinicalTrials.gov NCT03559491.

Project description:ObjectiveTo compare the efficacy and safety of intravitreal dexamethasone (DEX) implant and anti-vascular endothelial growth factor (anti-VEGF) agents in the treatment of macular oedema secondary to retinal vein occlusion (RVO).DesignSystematic review and meta-analysis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE).Data sourcesPubMed, Cochrane Library and ClinicalTrials.gov registry were searched from inception to 10 December 2019, without language restrictions.Eligibility criteriaRandomised controlled trials (RCTs) and real-world observation studies comparing the efficacy of DEX implant and anti-VEGF agents for the treatment of patients with RVO, naïve or almost naïve to both arms, were included.Data extraction and synthesisTwo reviewers independently extracted data for mean changes in best-corrected visual acuity (BCVA), central subfield thickness (CST) and product safety. Review Manager V.5.3 and GRADE were used to synthesise the data and validate the evidence, respectively.ResultsFour RCTs and 12 real-world studies were included. An average lower letter gain in BCVA was determined for the DEX implant (mean difference (MD) = -6.59; 95% CI -8.87 to -4.22 letters) administered at a retreatment interval of 5-6 months. Results were similar (MD6 months=-12.68; 95% CI -21.98 to -3.37 letters; MD12 months=-9.69; 95% CI -12.01 to -7.37 letters) at 6 and 12 months. The DEX implant resulted in comparable or marginally less CST reduction at months 6 and 12 but introduced relatively higher risks of elevated intraocular pressure (RR=3.89; 95% CI 2.16 to 7.03) and cataract induction (RR=5.22; 95% CI 1.67 to 16.29). Most real-life studies reported an insignificant numerical gain in letters for anti-VEGF drugs relative to that for DEX implant. However, the latter achieved comparable efficacy with a 4-month dosage interval.ConclusionCompared with anti-VEGF agents, DEX implant required fewer injections but had inferior functional efficacy and safety. Real-life trials supplemented the efficacy data for DEX implant.

Dataset Information

Treatment patterns of ranibizumab intravitreal injection and dexamethasone intravitreal implant for retinal vein occlusion in the USA.

Publications

Treatment patterns of ranibizumab intravitreal injection and dexamethasone intravitreal implant for retinal vein occlusion in the USA.

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