Néovascularisation rétro-fovéolaire du myope fort (photothérapie dynamique ou translocation rétiniene ?)

TOULOUSE3-BU Santé-Centrale (315552105) / SudocTOULOUSE3-BU Santé-Allées (315552109) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Extended Injection Intervals after Switching from Ranibizumab to Aflibercept in Macular Edema due to Central Retinal Vein Occlusion

Purpose. To assess treatment interval extension after switching from ranibizumab to aflibercept intravitreal injections in macular edema (ME) due to central retinal vein occlusion (CRVO) with an insufficient response or frequent recurrences to initial treatment. Methods. CRVO eyes treated with ranibizumab injections on a treat-and-extend (TAE) basis with an insufficient response or frequent recurrences were switched to aflibercept. Primary endpoint was the change in injection intervals before and after the switch. Results. Eleven eyes were included in this retrospective bicentric study. Before switching, patients received a mean number of 15.3 ranibizumab injections (range, 6–34) during a mean follow-up of 23.4 months (range, 6–57). After switching to aflibercept, patients received a mean number of 12.4 injections (range, 6–20) during a mean follow-up of 25.5 months (range, 16–38). Treatment interval could be extended from 6.1 (range, 4–8) to 11 weeks (range, 8–16) (p=0.001) corresponding to a mean extension of injection interval of +4.9 weeks. Conclusion. In case of insufficient response or frequent recurrences of ME due to CRVO in patients treated with ranibizumab on a TAE basis, switching to aflibercept could allow extending treatment intervals, which could reduce the injection burden for these patients

Real-world outcomes of ranibizumab treatment in French patients with visual impairment due to Macular Edema secondary to Retinal Vein Occlusion: 24-month results from the BOREAL-RVO study.

International audienceIntroduction: Information about real-world ranibizumab use is needed to optimize treatment of macular edema secondary to retinal vein occlusion (RVO). The BOREAL-RVO study assessed treatment use, effectiveness and safety of 24-month treatment with ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to RVO in a real-world setting. Methods: This was a multicenter, post-authorization, observational study in France, including patients starting ranibizumab for RVO. Primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at Month 6. Secondary endpoints were mean changes from baseline in BCVA at Month 24 and central retinal thickness (CRT) at Months 6 and 24, and treatment use in real-world setting. Results: 226 branch RVO (BRVO) and 196 central RVO (CRVO) patients were enrolled; 71.7% and 70.9% completed the 24-month follow-up, respectively. In BRVO, mean (SD) baseline BCVA was 55.2 (18.7) letters, with gains of 14.3 (13.7), 14.1 (16.5), 13.0 (17.5) and 11.4 (20.1) letters at Months 3, 6, 12 and 24. In CRVO, mean (SD) baseline BCVA was 40.4 (25.6) letters, with gains of 16.0 (21.2), 9.5 (25.4), 9.2 (27.7) and 8.3 (23.8) letters at Months 3, 6, 12 and 24. At Month 24, 52% of BRVO and 41% of CRVO patients had gains of 15 or more letters. In BRVO, mean (SD) CRT values at baseline and Months 3, 6, 12 and 24 were 550 (175), 315 (104), 343 (122), 335 (137) and 340 (105) μm. In CRVO, mean (SD) CRT values at baseline and Months 3, 6, 12 and 24 were 643 (217), 327 (152), 400 (203), 379 (175) and 348 (161) μm. On average, BRVO patients had 3.8 injections for 6.9 visits by Month 6, and 7.2 injections for 19.7 visits by Month 24. CRVO patients had 2.7 injections for 4.2 visits by Month 6, and 7.1 injections for 21.1 visits by Month 24. Factors predictive of better BCVA gain at Month 6 were age under 60 at baseline, lower baseline BCVA and BCVA gain at Month 3. There were no new safety findings. Conclusion: Major improvements in BCVA and CRT were observed at Month 3 after the induction phase, and then was sustained up to Month 24, with a slight decrease, probably due to under-treatment. This study demonstrated ranibizumab to be a safe and effective treatment for BRVO and CRVO in the real-world setting, although more regular or pro-active treatment could further improve outcomes

STAR: a randomized controlled trial for submacular hemorrhage secondary to age-related macular degeneration

Meeting presentations: Oral presentation at the American Academy of Ophthalmology Annual Meeting, 2022International audienceOBJECTIVE: To compare the efficacy and the safety of submacular hemorrhage (SMH) management with either surgical pars plana vitrectomy (PPV) or pneumatic displacement (PD), with tissue plasminogen activator (TPA) and vascular endothelial growth factor (VEGF) inhibitor added to each arm. DESIGN: Randomized, open-label, multicenter superiority study. PARTICIPANTS: Ninety patients with neovascular age-related macular degeneration (nAMD) aged ≥50 years, with recent SMH (≤14 days) greater than 2 optic disk areas and predominantly overlying the retinal pigment epithelium. INTERVENTIONS: Patients were randomly assigned to surgery (PPV, subretinal TPA [max 0.5 ml/50 μg], and 20% sulfahexafluoride [SF6] tamponade) or PD (0.05 ml intravitreal TPA [50 μg] and 0.3 ml intravitreal pure SF6). Both groups were asked to maintain a head upright position with the face forward at 45° for 3 days after intervention and received 0.5 mg intravitreal ranibizumab at the end of the intervention, at Month 1 and 2, as the loading phase, and then on a pro re nata regimen during a 6-month follow-up. METHODS AND OUTCOME MEASURES: The primary efficacy endpoint was mean best-corrected visual acuity (VA) change at Month 3. The secondary endpoints were mean VA change at Month 6, National Eye Institute 25-item Visual Function Questionnaire (VFQ-25) composite score value at Month 3 and 6, number of anti-VEGF injections, and complications during the 6-month follow-up. RESULTS: Of the 90 patients randomized, 78 (86.7%) completed the 3-month efficacy endpoint visit. The mean±SD age was 83.3±8.2 years, and 66.3% were female. The mean duration of symptoms before treatment was 7.5±4.4 days. The mean VA change from baseline to Month 3 in the surgery group (+16.8 letters, [95% CI, 8.7; 24.9]) was not significantly superior to the PD group (+16.4 letters, [95% CI, 7.1;25.7]; adjusted difference β, -1.9 [95% CI, -14.9;11.0], P = 0.767). Both groups achieved similar secondary outcomes at Month 6. No unexpected ocular safety concerns were observed in either group. CONCLUSIONS: Surgery did not yield superior visual gain nor additional benefit for SMH secondary to nAMD compared to PD at 3 months, with intravitreal anti-VEGF added to each arm. Both treatment strategies lead to a clinical improvement of visual acuity without safety concerns for SMH over 6 months. Both design and results of the trial cannot be used to establish equivalence between treatments

Management of diabetic macular edema with visual impairment in real-life practice in France: findings from the cross-sectional BOREAL DME study

Purpose: Diabetic macular edema (DME) is the leading cause of visual impairment (VI) in patients with diabetes. With the introduction of anti-vascular endothelial growth factor (anti-VEGF) agents, management of DME has evolved. The aim of this study was to identify the routine practice for the management of patients with VI due to DME (best-corrected visual acuity [BCVA] ≤ 20/40) in France in 2014. Methods: The cross-sectional, observational BOREAL DME study was conducted in a real-life practice in France on request of health authority. The study included patients with Type 1 or 2 diabetes aged ≥ 18 years who had a reduction in BCVA due to DME ( ≤ 20/40) irrespective of treatment prescribed at inclusion (including monitoring alone). The following medical data were collected from patients’ medical files: general patient characteristics, disease characteristics (including diabetes and DME), previous treatment for VI due to DME, and treatment prescribed at inclusion. Results: Of the 1023 screened patients, 918 were included in the study (Figure 1). The mean age of the patients was 67.0 years with an average 18.9 years of diabetes; 53.1% were male and 67.3% had bilateral DME (Table 1). For this analysis we included 1321 eyes with VI due to DME (BCVA ≤ 20/40; Figure 1). The majority of eyes (64.6%) had received prior treatment for reduction in BCVA due to DME. In the analyzed eyes, anti-VEGF (49.6%) was the most frequently prescribed treatment at inclusion followed by monitoring alone (41.1%). 65.9% of eyes with monitoring alone had received prior treatment. Corticosteroids were prescribed for 6.5% of eyes, while only 2.2% of eyes received laser. The mean BCVA and central retinal thickness were 53.5 letters and 415 μ m, respectively. Overall, 57.8% of eyes presented non-proliferative DR. In the treatment naïve eyes (n=459), 50.5% received ranibizumab, 40.5% had monitoring alone, and 3.9% each received laser and corticosteroids, respectively. Conclusions: The BOREAL DME study findings suggest that, in real-life practice in France, anti-VEGFs, primarily ranibizumab 0.5 mg, are the primary treatment for VI due to DME, followed by monitoring alone in 2014. Macular laser is currently rarely used in the French population

Management of diabetic macular edema with visual impairment in real-life practice in France: findings from the cross-sectional BOREAL DME study

Purpose: Diabetic macular edema (DME) is the leading cause of visual impairment (VI) in patients with diabetes. With the introduction of anti-vascular endothelial growth factor (anti-VEGF) agents, management of DME has evolved. The aim of this study was to identify the routine practice for the management of patients with VI due to DME (best-corrected visual acuity [BCVA] ≤ 20/40) in France in 2014. Methods: The cross-sectional, observational BOREAL DME study was conducted in a real-life practice in France on request of health authority. The study included patients with Type 1 or 2 diabetes aged ≥ 18 years who had a reduction in BCVA due to DME ( ≤ 20/40) irrespective of treatment prescribed at inclusion (including monitoring alone). The following medical data were collected from patients’ medical files: general patient characteristics, disease characteristics (including diabetes and DME), previous treatment for VI due to DME, and treatment prescribed at inclusion. Results: Of the 1023 screened patients, 918 were included in the study (Figure 1). The mean age of the patients was 67.0 years with an average 18.9 years of diabetes; 53.1% were male and 67.3% had bilateral DME (Table 1). For this analysis we included 1321 eyes with VI due to DME (BCVA ≤ 20/40; Figure 1). The majority of eyes (64.6%) had received prior treatment for reduction in BCVA due to DME. In the analyzed eyes, anti-VEGF (49.6%) was the most frequently prescribed treatment at inclusion followed by monitoring alone (41.1%). 65.9% of eyes with monitoring alone had received prior treatment. Corticosteroids were prescribed for 6.5% of eyes, while only 2.2% of eyes received laser. The mean BCVA and central retinal thickness were 53.5 letters and 415 μ m, respectively. Overall, 57.8% of eyes presented non-proliferative DR. In the treatment naïve eyes (n=459), 50.5% received ranibizumab, 40.5% had monitoring alone, and 3.9% each received laser and corticosteroids, respectively. Conclusions: The BOREAL DME study findings suggest that, in real-life practice in France, anti-VEGFs, primarily ranibizumab 0.5 mg, are the primary treatment for VI due to DME, followed by monitoring alone in 2014. Macular laser is currently rarely used in the French population

Real-world outcomes after 36 months treatment with ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (BOREAL-DME)

International audienceTo assess the efficacy, safety and follow-up of 36 months treatment with ranibizumab in patients with diabetic macular edema (DME) in real life setting. Methods This is a prospective phase 4 observational study. Between December 2013 and April 2015, 84 ophthalmologists enrolled a total of 290 adult patients initiating ranibizumab for visual impairment due to diabetic macular edema (DME) and treated them according to their routine practice. The primary outcome (mean change in best-corrected visual acuity [BCVA] after 12 months) was previously reported. Here we present outcomes after 36 months of follow-up for BCVA, change in central subfield thickness (CSFT) and report how participating ophthalmologists treated DME over a 3 year period (number of visits and injections, and evolution of treatment strategy). Results Of the 290 patients enrolled, 187 (64.5%) completed the 36 months of the study (entire cohort). In the entire cohort, 97 patients were treated exclusively with ranibizumab throughout the study and 90 patients switched to other intravitreal treatments. Mean BCVA was 64.2 (20.1) letters, representing a gain of +4.1 (19.9) letters from baseline to Month 36 (M36). CSFT improved over the study, and by M36 had decreased by 127 (138) µm compared to baseline. Over the 36 months of follow-up, patients in the entire cohort paid their ophthalmologists a mean of 30.9 (12.2) visits and had a mean of 7.6 (5.2) any injections Results for quality of life questionnaires NEI-VFQ25 and HUI-3 remained stable throughout the study. Multivariate analysis on the 145 patients with evaluable BCVA data at M36 found that male gender and milder baseline DME characteristics (BCVA ≥59 and CSFT <500 µm) were predictive factors for achieving a BCVA of ≥70 letters at M36. This study did not find any new safety signals, compared to the known profile of ranibizumab. Conclusions Gains in BCVA in this real life study were lower than those observed in randomized clinical trials with ranibizumab, mainly due to under treatment. Safety analysis of ranibizumab did not yield any new safety concerns