Functional and anatomical results after a single intravitreal Ozurdex injection in retinal vein occlusion: a 6‐month follow‐up – The SOLO study

Bezatis, Athanasios; Spital, Georg; Höhn, Fabian; Maier, Mathias; Clemens, Christoph R.; Wachtlin, Joachim; Lehmann, Florian; Hattenbach, L.-O.; Feltgen, Nicolas; Meyer, Carsten H.

doi:10.1111/aos.12020

Cited by 86 publications

(85 citation statements)

References 22 publications

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“…This compares favourably with results from the GENEVA trial, which showed a mean reduction of 119µm at 180 days following treatment [9], as well as other studies [14,18,19]. However there was no association between change in VA and change in CRT following treatment in our study, regardless of the baseline VA. As improvement in CRT does not necessarily reflect visual improvement, we surmise that resolution of ME on OCT scanning may leave residual macular atrophy or scarring with consequently little improvement in VA.…”

Section: Anatomical Outcomessupporting

confidence: 85%

Untitled

2015

OCR

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Section: Anatomical Outcomessupporting

confidence: 85%

Untitled

2015

OCR

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“…The relationship between duration of ME and the efficacy of DEX implant treatment seen in this study has also been reported in other studies. In the SOLO retrospective 6-month study, DEX implant treatment was associated with better improvement in CRT in BRVO of shorter duration [12]. Furthermore, in the GENEVA pivotal randomized clinical trials of DEX implant for treatment of RVO-associated ME, shorter duration of ME was associated with better improvement in BCVA and CRT after DEX implant treatment, especially in patients with BRVO [5].…”

Section: Discussionmentioning

confidence: 95%

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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“…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: 87%

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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Functional and anatomical results after a single intravitreal Ozurdex injection in retinal vein occlusion: a 6‐month follow‐up – The SOLO study

Cited by 86 publications

References 22 publications

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

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

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