Efficacy and Safety of Two or More Dexamethasone Intravitreal Implant Injections for Treatment of Macular Edema Related to Retinal Vein Occlusion (Shasta Study)

Capone, Antonio; Singer, Michael; Dodwell, David G.; Dreyer, Richard F.; Oh, Kean T.; Roth, Daniel B.; Walt, John G.; Scott, Lanita C; Hollander, David

doi:10.1097/iae.0b013e318297f842

Cited by 103 publications

(128 citation statements)

References 25 publications

(24 reference statements)

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“…The mean BCVA gain of +7.8 approxETDRS letters (between 1 and 2 lines in visual acuity) at 12 weeks in this study was similar to the gains in BCVA seen in previous large retrospective studies of real-world use of DEX implant in RVO [9,10]. DEX implant was effective in patients previously treated with anti-VEGF, consistent with a previous report that nine of ten patients with RVO ineffectively treated with anti-VEGF had improved BCVA and reduced CRT after DEX implant treatment [11].…”

Section: Discussionsupporting

confidence: 74%

“…For patients who received a second implant in this study, the mean time between the first and second implant was 155 days (approximately 5 months). This interval is consistent with the interinjection interval of 4.5 months reported in a prospective evaluation of DEX implant in patients with treatment-naïve RVO [21], and with the interinjection interval of 5.6 months reported in the SHASTA study, a large retrospective evaluation in patients with BRVO and CRVO who received at least two DEX implant injections [9]. The mean interval between DEX implant treatments was approximately 5 months (151 days) for patients in the SHASTA study who received no other treatment for RVO-associated ME during the study period [22].…”

Section: Discussionsupporting

confidence: 73%

“…Use of IOPlowering medication by patients in the study was consistent with medication use in the 6-month GENEVA pivotal trials of DEX implant in patients with RVO-associated ME, in which the percentage of eyes receiving IOP-lowering medication increased from 6 % at baseline to approximately 24 % at 6 months [4], as well as with medication use in a retrospective study of real-world use of DEX implant in Canada, in which 16.7 % of patients with RVO-associated ME who were treated with DEX implant required topical IOP-lowering medication [10]. A slightly higher percentage of patients (29-34 %) were reported to use or begin to use IOP-lowering medications in longer-term retrospective studies of real-world use of two or more DEX implant injections for treatment of RVO-associated ME in Germany and the United States [9,13]. The incidence of steroid-related cataract progression was very low, probably because of the relatively short study duration of 6 months.…”

Section: Discussionmentioning

confidence: 99%

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Dexamethasone intravitreal implant in retinal vein occlusion:real-life data from a prospective, multicenter clinical trial

Călugăru¹,

Călugăru²

2016

Graefes Arch Clin Exp Ophthalmol

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Purpose To evaluate the relationship between duration of macular edema associated with retinal vein occlusion (RVO) and the achievement of vision gain in patients receiving dexamethasone intravitreal implant (DEX implant) in real-world clinical practice, and to define patterns of use of DEX implant and its efficacy and safety in the treatment of patients with RVO in clinical practice. Methods This prospective, open-label, multicenter, 6-month observational phase IV study conducted at 70 sites in Germany enrolled patients diagnosed with macular edema following branch or central RVO (BRVO, CRVO) who were given DEX implant. Follow-up visits and evaluations occurred in accordance with normal clinical practice. Re-treatment with DEX implant and use of other RVO therapies was at the discretion of the treating physician. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline at week 12.Results The analysis population consisted of 573 patients (64 % BRVO, 36 % CRVO). Patients received a mean of 1.17 DEX implant treatments during the study period; 84.3 % of patients received a single DEX implant and 19.9 % received adjunctive other RVO treatment. Among patients with analyzable BCVA data at baseline and week 12 (n = 351), mean change from baseline BCVA at week 12 was −0.16 (standard deviation, 0.30) logMAR (+7.8 approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters) (p < 0.001), and 33.9 % of patients had gained at least 3 lines in BCVA from baseline. Mean change from baseline BCVA at week 12 was +9.5, +7.3, and +5.4 approximate ETDRS letters in patients with macular edema duration < 90 days, from 90 to 180 days, and >180 days respectively. Improvement in BCVA through week 24 and decreases in central retinal thickness were seen in both BRVO and CRVO. The most common adverse drug reaction was increased intraocular pressure. No glaucoma incisional surgeries were required. Conclusions DEX implant was effective in improving BCVA and central retinal thickness in patients with BRVO and CRVO in real-world clinical practice. The largest gains in BCVA over 6 months occurred in patients with recent onset macular edema, confirming the benefit of early treatment. DEX implant was well tolerated and had an acceptable safety profile.

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Section: Discussionsupporting

confidence: 74%

Section: Discussionsupporting

confidence: 73%

Section: Discussionmentioning

confidence: 99%

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Dexamethasone intravitreal implant in retinal vein occlusion:real-life data from a prospective, multicenter clinical trial

Călugăru¹,

Călugăru²

2016

Graefes Arch Clin Exp Ophthalmol

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“…Further ‘real-life' studies describing series of patients treated with Ozurdex for ME due to RVO in multicentric or single-center institutional settings have found clinically meaningful benefits and no serious adverse events [10,11,12,13,14,15,16,17,18]. However, 12-month clinical data have rarely been reported in the previous literature nor has analysis on treatment-naïve eyes with recent onset disease.…”

Section: Introductionmentioning

confidence: 91%

Intravitreal Dexamethasone Implant for Macular Edema Secondary to Retinal Vein Occlusion: 12-month Follow-Up and Prognostic Factors

Maggio

Polito²,

Guerriero³

et al. 2014

Ophthalmologica

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Purpose: To evaluate anatomical and visual outcomes following intravitreal dexamethasone implantation (Ozurdex) in eyes with visual loss due to macular edema (ME) secondary to retinal vein occlusion (RVO) and to identify predictive factors for improvement in best-corrected visual acuity (BCVA). Methods: We retrospectively analyzed medical records of 43 consecutive eyes with treatment-naïve ME secondary to recent onset RVO treated with repeated Ozurdex injections on a pro re nata basis. Results: The mean follow-up (FU) duration was 14 months (min. 12, max. 22). Both mean BCVA and central macular thickness improved significantly at the end of the FU period (p = 0.0001), and more than 30% of the eyes gained ≥3 lines within 3 months of repeated injections. Presence of foveal serous retinal detachment and macular ischemia were negatively associated with visual outcomes. Improvements were significantly associated with baseline BCVA and the integrity of the ellipsoid zone. No serious adverse events were recorded. Conclusions: In our study population, Ozurdex was a safe and effective therapeutic option for the treatment of ME associated with RVO. The results suggest that a comprehensive approach in the examination of RVO eyes may help to predict which patients are most likely to benefit from the treatment.

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“…Merkoudis et al 13 found a recurrence of macular edema between months 4 and 5 after the first DEX implant in eyes treated for RVO. However, other retrospective studies found a mean reinjection interval of 4.5, 5.3, and 5.6 months after treatment with DEX implants, [14][15][16] with a probable delay between recurrence and reinjection time. However, all patients with qualitative anatomical recurrence on SD-OCT imaging had functional recurrence at 14.44 days (SD = 42.18) on average after the first signs on OCT.…”

Section: Eyementioning

confidence: 96%

Anatomical and functional recurrence after dexamethasone intravitreal implants: a 6-month prospective study

Fortoul

Denis

Kodjikian

2015

Eye

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Purpose To evaluate the efficacy, safety, and delay of anatomical and functional recurrence after a first intravitreal injection of dexamethasone implant in eyes with cystoid macular edema (CME) secondary to retinal vein occlusion (RVO). Methods A 6-month prospective, monocentric and noncomparative case-series of 26 eyes of 26 patients. Best-corrected visual acuity (BCVA) and central subfield thickness (CST) were measured at baseline and each visit at 1 week, and months 1, 2, 3, 4, 5, and 6 after a first treatment. Primary efficacy outcome was the proportion of eyes with a minimum three-line improvement from baseline BCVA at each visit and at 6 months. We also defined different patterns of recurrence: qualitative anatomical recurrence, quantitative anatomical recurrence and functional recurrence. A P-value o5% was considered statistically significant. Results Mean population age was 69.3 years (SD = 12.2; range = 42-94 years). Mean ME duration before treatment was~9.2 months (SD = 11.43; range = 0.4-40 months). Eighty eight percent of eyes achieved a three-line improvement from baseline at 2 months (P = 0.02). The mean delay from baseline until qualitative anatomical, functional, or quantitative anatomical recurrence was 4.11 months (±0.86), 4.31 months (±1.33), and 4.40 months (±1.14), respectively. Qualitative anatomical recurrence occurred on average 14.4 days (SD = 42.18) before a minimum of one-line BCVA impairment (functional recurrence). Conclusion Dexamethasone intravitreal treatment seems to be effective for ME after RVO even with long-duration ME or poor visual acuity before treatment. Other longer studies should assess the delay of recurrence after second and further treatments with DEX implants or combined therapies for ME after RVO.

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Efficacy and Safety of Two or More Dexamethasone Intravitreal Implant Injections for Treatment of Macular Edema Related to Retinal Vein Occlusion (Shasta Study)

Abstract: Retinal vein occlusion patients treated with multiple DEX implant injections, either alone or combined with other therapies, had improved central retinal thickness and visual acuity with each subsequent injection. No new safety concerns developed with multiple implants.

Cited by 103 publications

References 25 publications

Dexamethasone intravitreal implant in retinal vein occlusion:real-life data from a prospective, multicenter clinical trial

Dexamethasone intravitreal implant in retinal vein occlusion:real-life data from a prospective, multicenter clinical trial

Intravitreal Dexamethasone Implant for Macular Edema Secondary to Retinal Vein Occlusion: 12-month Follow-Up and Prognostic Factors

Anatomical and functional recurrence after dexamethasone intravitreal implants: a 6-month prospective study

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