Monthly OCT monitoring of Ozurdex for macular oedema related to retinal vascular diseases: re-treatment strategy (OCTOME Report 1)

Mathew, Raeba; Pearce, Elizabeth; Muniraju, Ramu; Abdel-Hay, Ahmed; Sivaprasad, Sobha

doi:10.1038/eye.2013.287

Cited by 36 publications

(36 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Mathew et al [18] analyzed the morphological and functional changes following intravitreal Ozurdex injections in 30 patients with ME secondary to retinal vascular diseases. The authors evaluated the BCVA, contrast sensitivity, microperimetry, chromatic sensitivity, macular thickness and morphology using SD-OCT and fluorescein angiography at baseline and monitored monthly with BCVA and SD-OCT assessments up to 36 weeks.…”

Section: Discussionmentioning

confidence: 99%

Prospective Evaluation of Morphological and Functional Changes after Repeated Intravitreal Dexamethasone Implant (Ozurdex®) for Retinal Vein Occlusion

Bandello¹,

Parravano²,

Cavallero³

et al. 2015

Ophthalmic Res

View full text Add to dashboard Cite

Aims: To evaluate changes in macular morphology and function after repeated intravitreal dexamethasone implant (Ozurdex®) for macular edema (ME) due to retinal vein occlusion (RVO). Methods: Consecutive treatment-naïve patients with ME secondary to RVO were treated with Ozurdex and followed up to 12 months to evaluate functional and morphological outcomes by means of best-corrected visual acuity (BCVA) and microperimetry and by enhanced depth imaging optical coherence tomography, respectively. Results: Thirty-five eyes of 35 patients were included for the analysis (26 central RVO, 9 branch RVO). During the 12-month study period, 8 of the 35 eyes (23%) underwent 1 intravitreal dexamethasone implant, 13 of the 35 eyes (37%) underwent 2, and 14 of the 35 eyes (40%) underwent 3 intravitreal dexamethasone implants. At 1 month from the 1st intravitreal dexamethasone implant, the mean BCVA, retinal sensitivity and central macular thickness (CMT) significantly improved compared to the baseline values. At 3 months, the mean BCVA improvement was no more significant, while retinal sensitivity further improved and CMT slightly worsened, remaining, however, significantly better than at baseline. At 12 months, those eyes that had undergone 2 retreatments showed a significant improvement of the mean BCVA, mean retinal sensitivity and CMT compared to the baseline values [0.61 ± 0.29 logarithm of the minimum angle of resolution (LogMAR) vs. 0.82 ± 0.33 LogMAR, p = 0.011; 12.94 ± 4.73 dB vs. 10.75 ± 3.27 dB, p = 0.043, and 321 ± 91 µm vs. 735 ± 169 µm, p = 0.001, respectively]. In those eyes that had undergone only 1 retreatment, a significant improvement was recorded only for the CMT (500 ± 224 µm vs. 695 ± 302 µm, p = 0.044). The mean retreatment interval between the 1st and the 2nd injection was 4.5 ± 1.1 months (range 3-7 months), and between the 2nd and the 3rd injection it was 4.1 ± 1 months (range 3-6 months). Conclusions: In eyes with ME secondary to RVO, Ozurdex produces functional benefits as early as 1 month after treatment/retreatment. Current optical coherence tomography and microperimetry findings confirm the concept that, in most cases, the optimum retreatment interval should be <6 months from the 1st injection.

show abstract

Section: Discussionmentioning

confidence: 99%

Prospective Evaluation of Morphological and Functional Changes after Repeated Intravitreal Dexamethasone Implant (Ozurdex®) for Retinal Vein Occlusion

Bandello¹,

Parravano²,

Cavallero³

et al. 2015

Ophthalmic Res

View full text Add to dashboard Cite

show abstract

“…Therefore, a more frequent dosing between 16 and 20 weeks may be necessary to avoid the undulating effects on macular thickness and visual acuity. 11 A 16-weekly PRN dosing evaluated in the BEVORDEX study reported that 41% of the patients in the study improved ≥ 10 letters. 12 Therefore, a great deal of uncertainty still exists on the optimal dosing of Ozurdex to adopt for patients with DMO.…”

Section: Fast Track Paper Fast Track Papermentioning

confidence: 99%

A randomized clinical trial comparing fixed vs pro-re-nata dosing of Ozurdex in refractory diabetic macular oedema (OZDRY study)

Ramu

Yang

Menon

et al. 2015

Eye

Self Cite

View full text Add to dashboard Cite

Objective To compare the clinical effectiveness and safety of 5-monthly fixed dosing vs pro-re-nata (PRN) Ozurdex treatment in patients with refractory diabetic macular oedema (DMO). Design Prospective, multicentre, randomized active-controlled non-inferiority clinical trial. Participants Participants were 100 patients who attended Medical Retina Clinics for management of centre-involving refractory DMO. Interventions Participants were randomized 1 : 1 to either 5-monthly fixed dosing or optical coherence tomography (OCT)-guided PRN regimen of Ozurdex therapy for DMO. Data were collected on best-corrected visual acuity (BCVA), patient-reported outcome measures (PROM), macular thickness and morphology, diabetic retinopathy status, number of injections and adverse events from baseline for a period of 12 months. Main outcome measures The primary outcome was the difference between arms in change in BCVA from baseline to 12 months. The prespecified non-inferiority margin was five ETDRS letters. Key secondary outcomes included change in PROM scores, change in macular thickness, change in retinopathy and macular morphology, and safety profile. Results The mean change in BCVA was +1.48 (SD 14.8) in the fixed arm vs − 0.17 (SD 13.1) in the PRN arm, with adjusted effect estimate +0.97, 90% confidence interval (−4.01, +5.95), P = 0.02 (per protocol analysis). The conclusions of the ITT analysis were primarily supportive, − 0.34 (−5.49, 4.81) P = 0.07, but sensitive to an alternative assumption on missing data, +0.28 (−4.72, 5.27) P = 0.04. Conclusions The mean change in BCVA with 5-monthly fixed dosing of Ozurdex was non-inferior to OCT-guided PRN Ozurdex therapy for refractory DMO based on a per protocol analysis.

show abstract

“…When repeat treatment with DEX implant is indicated, the timing of re-treatment varies; however, on average, an interval shorter than 6 months is needed for sustained effectiveness [17][18][19][20]. 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).…”

Section: Discussionmentioning

confidence: 99%

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

Călugăru¹,

Călugăru²

2016

Graefes Arch Clin Exp Ophthalmol

View full text Add to dashboard Cite

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.

show abstract

Monthly OCT monitoring of Ozurdex for macular oedema related to retinal vascular diseases: re-treatment strategy (OCTOME Report 1)

Cited by 36 publications

References 16 publications

Prospective Evaluation of Morphological and Functional Changes after Repeated Intravitreal Dexamethasone Implant (Ozurdex®) for Retinal Vein Occlusion

Prospective Evaluation of Morphological and Functional Changes after Repeated Intravitreal Dexamethasone Implant (Ozurdex®) for Retinal Vein Occlusion

A randomized clinical trial comparing fixed vs pro-re-nata dosing of Ozurdex in refractory diabetic macular oedema (OZDRY study)

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

Contact Info

Product

Resources

About