Pharmacokinetics of a Sustained-Release Dexamethasone Intravitreal Implant in Vitrectomized and Nonvitrectomized Eyes

Chang-Lin, Joan-En; Burke, James A.; Peng, Qicong; Lin, Ton; Orilla, W.; Ghosn, Corine; Zhang, Kaiming; Kuppermann, Baruch D.; Robinson, Michael R.; Whitcup, Scott M.; Welty, Devin

doi:10.1167/iovs.10-6387

Cited by 161 publications

(127 citation statements)

References 41 publications

Supporting

Mentioning

114

Contrasting

Unclassified

Order By: Relevance

“…In our study, the outcomes for both improvement in BCVA and reduction in CRT following DEX-intravitreal implant seem to be equally good in eyes that have had prior PPV compared with those having an intact vitreous. This analysis finding shows consistency with the pharmacokinetic study previously reported by Chan-Ling et al 19 Our results demonstrated the effectiveness and good safety profile of DEX-intravitreal implant in uveitic ME. Our study has some limitations and should be interpreted in the context of the retrospective design and small number of patients.…”

Section: Discussionsupporting

confidence: 93%

Long-term evaluation of dexamethasone intravitreal implant in vitrectomized and non-vitrectomized eyes with macular edema secondary to non-infectious uveitis

Pelegrín

Maza

Molins

et al. 2015

Eye

View full text Add to dashboard Cite

Purpose To compare dexamethasone (DEX) intravitreal implant effect in nonvitrectomized (non-PPV) vs vitrectomized (PPV) eyes with macular edema (ME) secondary to non-infectious uveitis. Methods Medical records of patients with uveitic ME treated with DEX-intravitreal implant were reviewed. Main outcome measures were changes in central retinal thickness (CRT), best corrected visual acuity (BCVA), intraocular pressure (IOP), vitreous haze and adverse events. Statistical analysis was performed by Longitudinal Linear model using the General Estimating Equation methodology. Results Forty-two eyes of 32 patients were included. Median follow-up time was 18 months (interquartile range (IQR): 12-24). Median CRT showed its maximum decrease at the first month in non-PPV and PPV eyes without statistically significant differences between both groups (P = NS). Median Snellen BCVA, converted to logarithm (LogMAR), showed its maximum improvement at third month in both groups without statistically significant differences between them (P = NS). Median IOP was higher in non-PPV eyes than in PPV eyes from third (P = 0.025) to 12th month (P = 0.013). Vitreous haze score improved in both groups since first month and showed no differences (P = 0.706). Reinjection was performed in 45.2% of eyes at a median time of 5 months IQR: (5-6). Ocular hypertension (47.6%) was the most common adverse event.Conclusions DEX-intravitreal implant for uveitic ME has similar long-term safety profile and good response measured in terms of CRT decrease, BCVA, and vitreous haze improvement in both groups. Non-PPV eyes following DEX-intravitreal implant showed higher IOP increase than PPV eyes, showing the need for close IOP monitoring.

show abstract

Section: Discussionsupporting

confidence: 93%

Long-term evaluation of dexamethasone intravitreal implant in vitrectomized and non-vitrectomized eyes with macular edema secondary to non-infectious uveitis

Pelegrín

Maza

Molins

et al. 2015

Eye

View full text Add to dashboard Cite

show abstract

“…The pharmacokinetic profile of the 0.7 mg DEX implant in vitrectomized and nonvitrectomized eyes was studied in an animal model by Chang-Lin et al (2011). In this study, the concentration of DEX in the vitreous fluid and retina did not differ statistically significantly between the vitrectomized and nonvitrectomized eyes during each visit of 31 days of follow-up.…”

Section: Dex In Vitrectomized Eyesmentioning

confidence: 75%

Corticosteroids and Anti-Complement Therapy in Retinal Diseases

Narayanan

Kuppermann

2016

Handbook of Experimental Pharmacology

Self Cite

View full text Add to dashboard Cite

“…44 These results suggest that DEX implants may be particularly useful in the treatment of inflammation and MO in The peak effectiveness of the DEX implant was seen between 8 and 13 weeks after the injection. In this study, the efficacy of the DEX implant in reducing retinal thickness and improving BCVA in vitrectomised patients with DMO was similar to that seen in the subgroup of patients with DMO in the phase II study.…”

Section: Comparison Between Vitrectomised Versus Non-vitrectomised Pamentioning

confidence: 79%

“…[41][42][43][44] The mechanism for the effect of vitrectomy on DMO may involve both the release of vitreomacular traction and increased diffusion of advanced glycation end products, VEGF and other cytokines away from the retina. 41,44 These findings suggest that sustained drug delivery with an implant could be particularly useful in vitrectomised eyes, thus enhancing and boosting the primary effect of vitrectomy.…”

Section: Comparison Between Vitrectomised Versus Non-vitrectomised Pamentioning

confidence: 99%

Effectiveness of the Dexamethasone Intravitreal Implant for Treatment of Patients with Diabetic Macular Oedema

Dutra-Medeiros

Alkabes

Nucci

2014

European Endocrinology

View full text Add to dashboard Cite

Diabetic macular oedema (DMO) is a leading cause of vision loss in the working-age population worldwide. Corticosteroid drugs have been demonstrated to inhibit the expression of both the vascular endothelial growth factor (VEGF) gene and other anti-inflammatory mediators, such as prostaglandins. Triamcinolone, fluocinolone and dexamethasone are the main steroids that have been studied for the treatment of macular oedema. Over the last few years, several studies have suggested an important role for dexamethasone in the management of DMO. The dexamethasone intravitreal implant (DEX implant) (Ozurdex ® ; Allergan, Inc., Irvine, CA) is a novel approach approved by the US Food and Drug Administration (FDA) and by the EU for the intravitreal treatment of macular oedema after branch or central retinal vein occlusion, and for the treatment of non-infectious uveitis affecting the posterior segment of the eye. We reviewed manuscripts that had investigated the pharmacokinetics, efficacy and safety of the DEX implant regarding DMO treatment. KeywordsRefractory diabetic macular oedema, pathogenesis, inflammatory mediators, corticosteroids, dexamethasone intravitreal implant, implantable drug delivery system. 4 On the basis of the data from all 35 studies on more than 20,000 participants with diabetes, they estimated that among individuals with diabetes, the overall prevalence of any DR was 34.6 %, PDR was 7.0 %, DMO was 6.8 % and VTDR was 10.2 %. DR is a highly specific vascular complication of both type 1 and 2 diabetes, with prevalence strongly related to the duration of diabetes.5 In addition to the duration of diabetes, factors that increase the risk of, or are associated with, retinopathy include chronic hyperglycaemia, 6 nephropathy 7 and hypertension.8 Intensive diabetes management with the goal of achieving near-normoglycemia has been shown in large prospective randomised studies to prevent and/or delay the onset and progression of DR.9-11 Lowering blood pressure has been shown to decrease the progression of retinopathy. 12DMO is a frequent complication of DR and the most common cause of vision loss in patients with diabetes. Left untreated, up to 33 % of patients with DMO will experience moderate vision loss. 13 Laser photocoagulation has been considered, for a long time, as the main treatment option for DMO, based on the results of the Early Treatment Diabetic Retinopathy Study (ETDRS) clinical trial.14 Focal laser treatment reduced the risk of moderate visual loss in patients with DMO by 50 %. 15In more recent studies that involved only patients with DMO-associated vision loss, repeated applications of focal/grid laser photocoagulation treatment resulted in at least a 10-letter improvement in visual acuity in 28-32 % of patients, but 13-19 % of patients lost at least 10 letters in visual acuity. [16][17] In DMO, vascular leakage from dilated hyperpermeable capillaries and microaneurysms leads to accumulation of extracellular fluid in the macula. Inflammation has a key role in the pathogenesis and maintenan...

show abstract

Pharmacokinetics of a Sustained-Release Dexamethasone Intravitreal Implant in Vitrectomized and Nonvitrectomized Eyes

Cited by 161 publications

References 41 publications

Long-term evaluation of dexamethasone intravitreal implant in vitrectomized and non-vitrectomized eyes with macular edema secondary to non-infectious uveitis

Long-term evaluation of dexamethasone intravitreal implant in vitrectomized and non-vitrectomized eyes with macular edema secondary to non-infectious uveitis

Corticosteroids and Anti-Complement Therapy in Retinal Diseases

Effectiveness of the Dexamethasone Intravitreal Implant for Treatment of Patients with Diabetic Macular Oedema

Contact Info

Product

Resources

About