Post-marketing surveillance study of the safety of dexamethasone intravitreal implant in patients with retinal vein occlusion or noninfectious posterior segment uveitis

Tufail, Adnan; Lightman, Sue; Kamal, Ahmed; Pleyer, Uwe; Paniagua, N. Gajate; Dot, C.; Li, Xiao Yan; Jiao, Jenny; Lou, Jingjing; Hashad, Yehia

doi:10.2147/opth.s181256

Cited by 23 publications

(21 citation statements)

References 26 publications

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“…Combined therapy has the advantages of synergistic effect, improving visual acuity and prolonging injection intervals (Singer et al., 2012). Inflammation is also involved in the pathogenesis of macular edema after RVO and noninfectious posterior segment uveitis (NIPSU) (Tufail et al., 2018). Studies have shown that aqueous humor levels of proinflammatory cytokines are reduced after DEX treatment in patients with RVO (Rezar-Dreindl et al., 2017).…”

Section: Discussionmentioning

confidence: 99%

Mapping research trends of retinal vein occlusion from 2009 to 2018: a bibliometric analysis

Zhao

Shi

et al. 2019

PeerJ

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Objectives To map publication trends and explore research hotspots of retinal vein occlusion (RVO) study. Methods Based on Web of Science Core Collection (WoSCC), a bibliometric analysis was carried out. The knowledge map was constructed by VOSviewer v.1.6.10 to visualize the annual publication number, the distribution of countries, international collaborations, author productivity, source journals, cited reference and keywords in this field. Results A total of 2,135 peer-reviewed papers were retrieved on RVO from 2009 to 2018. The United States ranks highest among countries with the most publications and the most active institution was Kyoto University. Noma H contributed the most publications in this field. Retina—The Journal of Retinal and Vitreous Disease was the most prolific journal in RVO research. The top cited references mainly presented anti-VEGF medications on the management of RVO. The keywords formed six clusters: (1) Risk factors and pathogenesis of RVO; (2) Metabolismof RVO; (3) Therapeutic use of corticosteroids on RVO; (4) Diagnostic methodsof RVO; (5) Management of macular edema secondary to RVO (6) Anti-VEGFtreatment of RVO. Conclusions The six major research hotspots could provide an insight into RVO research and valuable information for researchers to identify potential collaborators and partner institutions.

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Section: Discussionmentioning

confidence: 99%

Mapping research trends of retinal vein occlusion from 2009 to 2018: a bibliometric analysis

Zhao

Shi

et al. 2019

PeerJ

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“…Although approved for the treatment of the underlying intraocular inflammation, a survey among uveitis specialists identified uveitic CME as the preferred indication [ 12 , 13 ]. Ozurdex® [ 14 ] appears less prone to high intraocular pressure and cataract occurrence than Retisert®. Iluvien® is a non-bio-degradable, 0.19 mg fluocinolone acetonide implant lasting up to 36 months [ 15 ].…”

Section: Intravitreal Therapymentioning

confidence: 99%

New pharmacotherapy options for noninfectious posterior uveitis

2021

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Introduction Noninfectious inflammation of the posterior eye segment represents an important cause of visual impairment. It often affects relatively young people and causes a significant personal and social impact. Although steroids and nonbiologic- Disease-Modifying Antirheumatic Drugs (nbDMARDs) are effective both in acute and long- lasting diseases, however they are increasingly being replaced by biologic (DMARDs). bDMARD. This article therefore aims to identify recent advances in the therapy of noninfectious posterior segment uveitis. Methods A Medline-search was conducted using the terms: nbDMARD, bDMARD, posterior uveitis, intermediate uveitis, treatment, corticosteroid. In addition, clinical studies were included as registered at ClinicalTrials.gov. Results Currently two major lines of treatments can be identified: (1) the intraocular application of anti-inflammatory agents and (2) the introduction of new agents, e.g., (bDMARDs) and small-molecule-inhibitors. Whereas intravitreal treatments have the advantage to avoid systemic side effects, new systemic agents are progressively earning credit on the basis of their therapeutic effects. Conclusion Even when current treatment strategies are still hampered by the limited number of randomized controlled trials, promising progress and continuous efforts are seen.

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“…23,35 The AEs that occurred (increased IOP and cataract) were expected with intraocular corticosteroid treatment, and the observed safety profile of DEX was consistent with that reported in previous studies of DEX treatment for DME 23,28,38 and other indications. 39,40 Typically the increases in IOP in DEX-treated eyes were managed with topical IOP-lowering medication, and after IOP control was achieved, patients received subsequent DEX injections as planned. Only 1 (0.7%) DEX-treated patient required trabeculectomy, consistent with findings from the global registration studies in which 2 (0.6%) DEX-treated patients required trabeculectomy.…”

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confidence: 99%

Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region

Wei¹,

Chen²,

Hu³

et al. 2021

OPTH

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Purpose: To evaluate the safety and efficacy of dexamethasone intravitreal implant 0.7 mg (DEX) compared with laser photocoagulation in patients with diabetic macular edema (DME). Patients and Methods: This Phase 3, multicenter, randomized, efficacy evaluator-masked, parallel-group, 12-month clinical study enrolled adults in China and the Philippines with reduced visual acuity secondary to fovea-involved DME in the study eye. Participants were randomized 1:1 to study eye treatment with laser photocoagulation every 3 months as needed (n = 139) or DEX every 5 months (n = 145). The main efficacy measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and leakage area. The primary endpoint was the average change in BCVA from baseline over 12 months (area-under-the-curve method). Preplanned subgroup analyses evaluated outcomes in Chinese patients. Results: Mean average change in BCVA from baseline during the study (letters) was 4.3 with DEX (n = 145) versus 1.4 with laser (n = 127) overall (P = 0.001) and 4.6 with DEX (n = 129) versus 0.6 with laser (n = 113) in Chinese patients (P < 0.001). At Month 12, mean change in CRT from baseline was −209.5 μm with DEX versus −120.3 μm with laser (P < 0.001) and mean change in total leakage area from baseline was −8.367 mm 2 with DEX versus −0.637 mm 2 with laser (P < 0.001). The most common treatment-emergent adverse events in the DEX group were increased intraocular pressure and cataract. Conclusion: DEX administered every 5 months provided significantly greater improvement in BCVA, CRT, and total leakage area compared with laser treatment. DEX demonstrated an acceptable safety profile, consistent with an intraocular corticosteroid, and similar to that reported in completed global registration studies.

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Post-marketing surveillance study of the safety of dexamethasone intravitreal implant in patients with retinal vein occlusion or noninfectious posterior segment uveitis

Cited by 23 publications

References 26 publications

Mapping research trends of retinal vein occlusion from 2009 to 2018: a bibliometric analysis

Mapping research trends of retinal vein occlusion from 2009 to 2018: a bibliometric analysis

New pharmacotherapy options for noninfectious posterior uveitis

Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region

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