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.

INTRODUCTION: 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, respectively. 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, respectively. 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 were 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 proactive treatment could further improve outcomes.

Real-World Outcomes after 36-Month Treatment with Ranibizumab 0.5 mg in Patients with Visual Impairment due to Diabetic Macular Edema (BOREAL-DME).

PURPOSE: To assess the efficacy, safety, and follow-up of 36-month 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 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 and 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 undertreatment. Safety analysis of ranibizumab did not yield any new safety concerns.

Expectations and fears of patients with diabetes and macular edema treated by intravitreal injections.

AIMS: Clinical outcomes of diabetic macular edema (DME) have been widely described, but data on diabetic retinopathy perceptions by diabetes patients are limited. The aim of this survey was to explore the lived experience, knowledge, fears and expectations about disease, and treatment in patients with diabetes and macular edema treated with intravitreal injections (IVTI) and to characterize patient profiles. METHODS: Cross-sectional survey including a preliminary qualitative phase (20 patients with DME, treated or treatment-naive, 5 female and 15 male, age 36-74 years) followed by a quantitative survey (116 patients treated with IVTI for DME). Data ASKIA Analyze (version 5.3.3.5) was used for descriptive statistics, and R software (version 3.4.1) for multiple correspondence analysis. RESULTS: The qualitative phase identified the wording used by patients and information helpful to propose modalities of response in the quantitative phase. In the quantitative survey (116 patients, mean age 66.6 years), most patients were treated with anti-vascular endothelial growth factor. Overall, 71.9% reported that the disease negatively affected their daily activities and 33.1% considered that regular visits to the ophthalmologist were disrupting their life. Treatment expectations differed significantly between patients in terms of disease experience (visit and injection schedules), fears and feelings, and relationship with physicians, allowing three patient profiles to be identified: "Worried" patients (n = 45) felt isolated and were worried about the need for repeated treatment and possible side effects. They were mainly active men aged < 60 with type I diabetes (T1D) and DME diagnosed for > 2 years; "Curious" patients (n = 21) experienced insufficient support and requested more information on their disease and existing treatments. They were mainly single women aged 60-69 years; "Passive" patients (n = 50) felt sufficiently informed by their ophthalmologist and were not concerned by DME. They were older (mean age: 70 years) and mainly type 2 diabetic men. CONCLUSIONS: Patients with diabetes and macular edema treated with IVTI form a heterogeneous group regarding fears and expectations. Different patient profiles were identified and need to be confirmed in larger studies. A better understanding of psychological profiles may optimize compliance of diabetic patients.

Impact of ranibizumab on visual impairment in patients with bilateral diabetic macular edema.

AIMS: Diabetic macular edema (DME) frequently presents bilaterally. In case of bilateral retinal disease, the visual impairment (VI) and the visual acuity (VA) are strongly correlated to the better eye. The aim of this study was to assess the impact of ranibizumab intravitreal injections (IVR) on VI in patients with simultaneous VA loss due to DME. METHODS: This was a retrospective two-center study including consecutive DME patients with visual loss treated with ranibizumab since November 2011 and with a minimum follow-up of 6 months. Patients with bilateral visual decrease from DME undergoing IVR within 6 months of each other were included. RESULTS: Twenty-nine DME patients who received bilateral IVR within a 6-month interval in the second eye were included. At baseline, 82.8% (n = 24) of patients had a VA < 20/40 in their better eye versus 44.8% (n = 13) of patients at the end of follow-up, i.e. a reduction by 45.9% of VI. In the better eye, the mean VA was 57.3, 65.0 and 65.5 ETDRS letters, respectively, at baseline, month 3 and month 6 (mean VA gain +8.2 letters). In the worse eye, the mean VA was 44.2, 53.5 and 53.8 ETDRS letters, respectively, at baseline, M3 and M6 (mean VA gain +9.6 letters). CONCLUSIONS: In patients with bilateral DME, subsequent ranibizumab IVR reduced VI frequency.

Clinical applications of optical coherence tomography angiography: What we have learnt in the first 3 years.

A review of the literature from 2014 to 2016 was conducted, focusing on the results of optical coherence tomography angiography in different chorioretinal diseases. In only 3 years, optical coherence tomography angiography has been shown to be an effective tool for diagnosing choroidal neovascularization complicating age-related macular degeneration, pathologic myopia, and inflammatory conditions. The technique has sometimes been considered superior to conventional multimodal imaging, for example, in choroidal neovascularization associated with chronic central serous chorioretinopathy or multifocal choroiditis. In retinal vascular diseases, optical coherence tomography angiography has helped to understand the condition described as paracentral acute middle maculopathy and has been considered highly effective for the analysis of retinal vascular macular changes secondary to retinal vein occlusion or macular telangiectasia. Changes in the foveal avascular zone, also reported in diabetic maculopathy, have been shown to occur before any angiographic signs. A reduction in capillary vascular density has been reported in the fovea of eyes with malignant melanoma, but not in eyes with choroidal nevus. However, optical coherence tomography angiography is a recent technique that probably needs refinements and further studies. Nevertheless, the first 3 years of optical coherence tomography angiography use suggest its clinical relevance and useful applications in daily clinical practice.

Functional and Anatomical Outcomes in Patients With Serous Retinal Detachment in Diabetic Macular Edema Treated With Ranibizumab.

Purpose: To assess the effect of serous retinal detachment (SRD) on functional and anatomical outcomes in ranibizumab-treated patients with diabetic macular edema (DME). Methods: All consecutive ranibizumab-treated patients with SRD were included in this retrospective study. For each patient with SRD, a patient without SRD with the same baseline best-corrected visual acuity (BCVA) was randomly included for adjustment on their baseline BCVA. All patients with SRD were included in group 1 (G1) and those without SRD in G2. The primary endpoint was the mean change in BCVA between baseline and month 12 (M12). Secondary endpoints were the mean change in central retinal thickness (CRT) between baseline and M12, injection number, and proportion of patients who gained/lost ≥15 letters. Results: Seventy-eight eyes were included, 39 in each group. Baseline BCVA was similar in both groups (45.2 and 45.3 letters). Mean change in BCVA between baseline and M12 was not statistically different: 11 ± 12 letters in G1 and 12 ± 13 letters in G2 (P = 0.78). Baseline CRT was 650 ± 130 µm in G1 and 480 ± 79 µm in G2. Mean change in CRT was -235 ± 170 µm in G1 and -130 ± 96 µm in G2 (P = 0.013). Patients received 5.2 and 5.5 injections in G1 and G2 (P = 0.46). In group 1, 38.5% and 2.6% of patients respectively gained and lost ≥15 letters versus 41% (P = 0.1) and 5.1% (P = 0.1) in G2. Conclusions: Similar BCVA gains were observed regardless of the presence of SRD. The higher visual gain usually observed in DME with SRD could be associated with a lower baseline BCVA.

RETICULAR PSEUDODRUSEN ARE NOT A PREDICTIVE FACTOR FOR THE 1-YEAR RESPONSE TO INTRAVITREAL RANIBIZUMAB IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.

PURPOSE: To investigate reticular pseudodrusen (RPD) as a potential baseline factor predictive of a poor 1-year response to intravitreal ranibizumab in eyes with neovascular age-related macular degeneration. METHODS: Retrospective, monocentric case series including 98 consecutive naive neovascular age-related macular degeneration patients. Presence of RPD was assessed by two graders based on color, blue-light, fundus autofluorescence pictures, and spectral-domain optical coherence tomography. A correlation between the presence of RPD and the visual change was investigated. Other baseline characteristics studied in a monovariate and multivariate analysis were the following: age, gender, affected side, loading dose, type of neovascularization, presence of retinal pigment epithelial detachment >250 µm, subretinal or intraretinal fluid, blood over >50% of the lesion, and subfoveal choroidal thickness. RESULTS: The presence of RPD was not associated with a visual change (P = 0.96), but with a thin subfoveal choroidal thickness at baseline (P < 0.0001). The monovariate analysis showed that the presence of blood at baseline was associated with visual gain (P = 0.007). CONCLUSION: The presence of RPD at baseline was not identified as a factor associated with a poor 1-year response to ranibizumab in eyes with neovascular age-related macular degeneration. Studies with a longer follow-up may be needed to assess the impact of RPD on the visual prognosis of eyes with neovascular age-related macular degeneration.

Outcomes after a 1-Year Treatment with Ranibizumab for Diabetic Macular Edema in a Clinical Setting.

PURPOSE: The aim of this study was to assess the efficacy and safety of ranibizumab in patients with diabetic macular edema (DME). METHODS: We conducted a retrospective analysis of consecutive patients with vision loss due to DME who were treated with ranibizumab. All patients received a loading dose of 3 monthly injections followed by re-treatments on an as-needed basis. The primary endpoint was the change in best-corrected visual acuity (BCVA) at 12 months. Secondary endpoints were the change in central retinal thickness (CRT) and the number of intravitreal injections (IVI) at 12 months. RESULTS: One hundred and six eyes of 78 patients were included. BCVA changed from 48.3 (20/100) letters at baseline to 59.0 letters (20/63) at 12 months (p < 0.0001; mean gain: +10.7 letters), and 38% of the patients had a final BCVA >70 letters. CRT decreased from 519 µm at baseline to 355 µm at 12 months (p < 0.0001). The threshold of the first quartile of the baseline VA was 40 letters. Patients with a baseline VA >40 letters had a higher final VA of 66 ± 14 letters (20/50) versus 43 ± 18 letters (20/125) for patients with a baseline VA ≤40 letters (p < 0.0001). A mean number of 5.4 (3-10) IVI were administered. CONCLUSION: This study conducted in a clinical setting confirms the results of previous randomized trials. The final BCVA was mainly influenced by the baseline BCVA, which supports the utility of early DME treatment before patients experience a severe vision loss.

Dexamethasone implant confined in Berger's space.

We reported a new complication after dexamethasone implant injection. The patient was treated by dexamethasone implant injection for diabetic macular edema. After injection, we report an implant stucked in Berger's space behind the crystalline lens capsule in the visual axis. This situation resolved after cataract surgery and the implant moved to a less inconvenient localization.

Estimation of the need for bilateral intravitreal anti-VEGF injections in clinical practice.

BACKGROUND: To estimate the need for bilateral intravitreal anti-VEGF injections in patients treated for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion, choroidal neovascularization (CNV) in high myopia, and other causes of CNV. METHODS: All consecutive patients treated with intravitreal anti-VEGF injection over a 1-month period were included in a prospective multicenter survey. The reason for intravitreal anti-VEGF injection and the involvement of the fellow eye in the pathology requiring a treatment with intravitreal anti-VEGF were recorded. A time interval between bilateral injections longer than 1 month, within a 1-month period, and same-day bilateral injections were recorded. RESULTS: A total of 1335 patients were included, corresponding to 1024 (76.7 %) patients treated for nAMD, 167 (12.5 %) for DME, and 144 (10.8 %) for other reasons. Four hundred and fifty-nine (34.4 %) patients were treated bilaterally with a time interval between injections longer than 1 month, 170 (12.7 %) were treated bilaterally within a 1-month interval, and 87 (6.6 %) had same-day bilateral injections. Bilateral injections were more frequent in diabetic patients than in nAMD patients (respectively 48 % vs. 36 %, p = 0.0033). CONCLUSIONS: Patients with DME are more likely to be treated bilaterally with anti-VEGF injections. As the rate of second eye involvement requiring treatment increases progressively over time, a same-day bilateral injection strategy will become more common as it decreases the administrative burden on the healthcare system and treatment burden experienced by patients.

Using Patient-Level Data to Develop Meaningful Cross-Trial Comparisons of Visual Impairment in Individuals with Diabetic Macular Edema.

INTRODUCTION: The aim of this study was to assess the impact of baseline characteristics on visual outcome of patients with diabetic macular edema and compare the results of clinical trials with different patient populations. METHODS: A model was created with patient-level data from the RESPOND/RESTORE trials to estimate the impact of baseline characteristics on increases in best-corrected visual acuity (BCVA) with anti-vascular endothelial growth factor therapies, measured by letters gained on the Early Treatment Diabetic Retinopathy Study scale from baseline to month 12. Mean BCVA gains with ranibizumab 0.5 mg pro re nata or laser photocoagulation monotherapy were predicted, assuming baseline characteristics equivalent to those in the VIVID-DME/VISTA-DME trials. These results were compared with the gain with aflibercept 2.0 mg every 8 weeks in VIVID-DME/VISTA-DME. Sensitivity analyses assessed outcome robustness. RESULTS: Baseline BCVA and central retinal thickness differed significantly between trials. In unadjusted data, patients in RESPOND/RESTORE receiving ranibizumab gained an additional 6.6 letters [95% confidence interval (CI): 4.5-8.7] compared with patients receiving laser monotherapy. After adjusting data to assume baseline characteristics equivalent to VIVID-DME/VISTA-DME, patients receiving ranibizumab were predicted to gain an additional 9.9 letters (95% CI: 7.3-12.4) compared with those receiving laser monotherapy. These results were similar (0.1-letter difference in favor of aflibercept; 95% CI: -2.9 to 3.2; P = 0.94) to the gain in BCVA in patients receiving aflibercept in VIVID-DME/VISTA-DME compared with those receiving laser monotherapy (10.0 letters, 95% CI: 8.3-11.7). CONCLUSION: After adjusting for baseline characteristics, the difference in letters gained between patients receiving ranibizumab versus aflibercept was non-significant across trials, highlighting the importance of adjusting for baseline characteristics in future comparisons. FUNDING: Novartis Pharma AG.

Review and comparison of methodologies for indirect comparison of clinical trial results: an illustration with ranibizumab and aflibercept.

AIM: To review and compare methods for indirect comparison of aflibercept and ranibizumab in patients with diabetic macular edema. METHODS: Post-stratification, inverse probability weighting based on simulated data, weight optimization, and regression model techniques were used to compare pooled individual patient-level data from the RESTORE and RESPOND (ranibizumab 0.5 mg as needed after 3 initial monthly doses) studies with summary-level data from the VIVID and VISTA (aflibercept 2.0 mg every 8 weeks after 5 initial monthly doses, 2q8) studies. The impact of adjusting for up to two baseline characteristics was assessed. RESULTS: All methods provided similar results. After adjustment for baseline best-corrected visual acuity and central retinal thickness, no statistically significant difference in average gain in baseline best-corrected visual acuity from baseline at month 12 was found between ranibizumab 0.5 mg and aflibercept 2q8. CONCLUSIONS: Weight optimization and regression methods are useful options to adjust for more than one baseline characteristic.

Ranibizumab 0.5†mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study.

AIMS: To demonstrate non-inferiority of ranibizumab treat-and-extend (T&E) with/without laser to ranibizumab pro re nata (PRN) for best-corrected visual acuity (BCVA) in patients with diabetic macular oedema (DMO). METHODS: A 24-month single-masked study with patients randomised 1:1:1 to T&E+laser (n=121), T&E (n=128) or PRN (control; n=123). All patients received monthly injections until BCVA stabilisation. The investigator decided on re-treatment in the PRN and treatment-interval adaptations in the T&E groups based on loss of BCVA stability due to DMO activity. Likewise, laser treatment was at investigator's discretion. Collectively, these features reflect a real-life scenario. Endpoints included mean average change in BCVA from baseline to months 1-12 (primary), mean BCVA change from baseline to months 12 and 24, treatment exposure and safety profile. RESULTS: Both T&E regimens were non-inferior to PRN based on mean average BCVA change from baseline to months 1-12 (T&E+laser: +5.9 and T&E: +6.1 vs PRN: +6.2 letters; both p<0.0001). Mean BCVA change at month 24 was similar across groups (+8.3, +6.5 and +8.1 letters, respectively). The mean number of injections was 12.4 and 12.8 in the T&E+laser and T&E groups and 10.7 in the PRN group. The T&E regimens showed 46% reduction in the number of clinic visits. Over 70% of patients maintained their BCVA, with treatment intervals of ≥2 months over 24 months. Safety profile was consistent with that described in the product information. CONCLUSIONS: T&E is a feasible treatment option for patients with DMO, with a potential to reduce treatment burden. Slightly more injections were required versus PRN, likely due to the specifics of the T&E regimen applied here. TRIAL REGISTRATION NUMBER: NCT01171976.

BRIDGE ARCH-SHAPED SEROUS RETINAL DETACHMENT IN AGE-RELATED MACULAR DEGENERATION.

PURPOSE: To describe bridge arch-shaped serous retinal detachment (SRD) in exudative age-related macular degeneration and evaluate its functional outcomes. METHODS: In this monocentric, retrospective, noncomparative case series, patients were included. Patients with exudative age-related macular degeneration and bridge arch-shaped SRD treated with ranibizumab were included. Anatomical patterns of SRD and functional outcomes were assessed. RESULTS: Twenty-two eyes with bridge arch-shaped SRD of 22 patients with age-related macular degeneration were included. Serous retinal detachments were characterized by a steep angle at the junction between the retinal pigment epithelium and the sensory retina (mean, 53.45 ± 12.5°), and characterized by the presence of adhesion areas between the sensory retina and a fibrous complex developed from the choroidal neovascularization. In 15 eyes, the choroidal neovascularization was classic choroidal neovascularization and a fibrotic evolution was observed. Serous retinal detachments were compartmentalized in 14 eyes, leading to a multipocket structure. Visual acuity decreased from 49.9 ± 19.2 letters (20/100) to 40.3 ± 18.6 letters (20/160), corresponding to a mean change of -9.6 ± 19.4 letters. CONCLUSION: This was the first study to describe the specific morphologic features of bridge arch-shaped SRD, a previously undescribed type of SRD complicating exudative age-related macular degeneration. Patients with bridge arch-shaped SRD responded to intravitreal injections of ranibizumab, but their visual prognosis was unfavorable, compared with the literature. The presence of bridge arch-shaped SRD seemed to be a marker for the fibrotic evolution of the choroidal neovascularization.

PERIPAPILLARY RETINAL PIGMENT EPITHELIUM CHANGES IN AGE-RELATED MACULAR DEGENERATION.

PURPOSE: To describe peripapillary retinal pigment epithelium changes observed in patients with age-related macular degeneration (AMD) and evaluate their prevalence. METHODS: This study is a prospective, monocentric, comparative case series including 104 consecutive patients with AMD, and 34 patients who are more than 60 years old and consulting for other conditions (control group). Color and fundus autofluorescence images centered on the optic disk were taken and graded by 2 independent readers from 0 to 4: 0, absent; 1, uneven background; 2, focal hyperautofluorescent dots and spots; 3, light reticular pattern; 4, dense reticular pattern. Statistical analysis was performed to correlate the presence of peripapillary retinal pigment epithelium changes with age, sex, and AMD subtype. RESULTS: Peripapillary retinal pigment epithelium changes were observed in 76/104 AMD eyes (73.0%) and were significantly more frequent than in eyes with other conditions (14/34, 41.1%, P = 0.002), whereas groups did not differ for age (P = 0.14). Grade ≥2 peripapillary retinal pigment epithelium changes were more frequently observed in patients with AMD than in controls (41.3 vs. 17.6%, P = 0.013). No differences were found between patients with AMD having peripapillary retinal pigment epithelium changes and other patients for age distribution (P = 0.14), sex ratio (P = 0.34), or AMD type (P = 0.57). CONCLUSION: Peripapillary retinal pigment epithelium changes were more frequent in patients with AMD than in controls, and when present, they were of higher grade. Peripapillary retinal pigment epithelium changes significance is not yet understood and needs further evaluation.

Long-term variable outcome of myopic choroidal neovascularization treated with ranibizumab.

PURPOSE: The purpose was to evaluate the long-term efficacy of ranibizumab for the treatment of myopic choroidal neovascularization (CNV) in a clinical setting. METHODS: This was a retrospective, monocentric, noncomparative analysis of 51 eyes of 51 patients with naïve juxtafoveal or subfoveal myopic CNV treated with intravitreal ranibizumab (IVR) on a pro re nata basis for at least 24 months. The patients' demographic data were recorded, including the best-corrected visual acuity (BCVA) measured with an ETDRS chart, location of the CNV, grade of myopic changes, central foveal thickness (CFT), and number of administered IVR. Outcome measures were to determine the changes in BCVA, identify the factors influencing the visual outcome, compare the best visual gain obtained for each treated eye with the final visual gain, and identify the cause of the relative decline in the visual acuity, when present. RESULTS: BCVA improved from 58.7 ± 19.0 letters at baseline to 66.3 ± 16.2 letters at the final visit (P = 0.001; mean visual gain: +7.6 ± 15.6 letters). Multivariate analysis did not identify any correlation between the visual gain and age, sex, grade of myopic fundus changes, CNV location, or initial protocol. The mean IVR number was 3.5 ± 2.8 injections (range 1-12; median 3) for a mean follow-up of 39.3 ± 11.3 months (range 24-69). Twenty-one eyes experienced a relative decline in BCVA during the follow-up, which was attributable in 16 cases to myopic atrophic changes. CONCLUSIONS: Intravitreal ranibizumab resulted in long-term efficacy in the treatment of myopic CNV. However, some eyes may present a long-term relative decline in their initial visual gain.

Intravitreal ranibizumab and/or dexamethasone implant for macular edema secondary to retinal vein occlusion.

PURPOSE: To investigate the outcome of intravitreal ranibizumab and/or dexamethasone implant treatment for treatment of macular edema (ME) secondary to central or branch retinal vein occlusion (CRVO or BRVO) in a clinical setting. METHODS: Retrospective analysis of consecutive patients followed for at least 6 months. Data recorded included the type of occlusion, initial and final visual acuity, and number of injections. RESULTS: Sixty-five patients were included, 26 had CRVO and 39 BRVO. Mean (± SD) follow-up duration was 16 (± 7.7) months. Twenty-four (36.9%) patients received ranibizumab in monotherapy, 19 patients (29.3%) dexamethasone in monotherapy, and 22 patients (33.8%) received successively both treatments. In dexamethasone-treated patients, mean (± SD) visual acuity gain was 5.8 ± 10.7 letters for BRVO and 16.8 ± 15.6 letters for CRVO. In ranibizumab-treated patients, mean (± SD) visual acuity gain was 9.2 ± 10 letters for BRVO and 18.2 ± 20.5 letters for CRVO. CONCLUSION: Both intravitreal ranibizumab and dexamethasone intravitreal implant could be used as first-line therapy for patients with ME secondary to retinal vein occlusion.

Ranibizumab for exudative AMD in a clinical setting: differences between 2007 and 2010.

BACKGROUND/PURPOSE: Visual results of ranibizumab given pro re nata in clinical settings depend greatly from the achievement of the monthly follow-up. In 2007, a previous study performed in our tertiary care showed a mean visual gain of only + 0.7 ETDRS chart letters, probably because of insufficient number of follow-up visits and injections. We report a second retrospective study of patients whose eyes were treated in the same setting, and whose first injection was performed after April 1 2010. The aim was to check if the changes in the management of AMD patients between 2010 and 2007 achieved better visual results. METHOD: One hundred and twenty-two patients (125 eyes) with exudative age-related macular degeneration (AMD) were included. Age, gender, side, type of CNV, VA measured on an ETDRS chart at baseline and at 52 ± 6 weeks, the number of IVT performed, and follow-up visits were recorded. The series was compared to our former series of the year 2007. Results are expressed as means ± standard deviation. Mann-Whitney's non-parametric test was used to compare the statistical distribution of the parameters measured. Fisher's exact test was used for 2 × 2 categorical variables, and the chi-square test for others. RESULTS: In the 2010 series, the mean visual gain was +6.0 ± 11.0 l (-35 to + 34). During this period, the eyes had 5.0 ± 1.8 IVT and 7.8 ± 1.4 follow-up visits. No correlation was found between the change in VA and gender, type of CNV, age, or the numbers of IVT and visits. There was a reverse correlation between baseline VA and VA changes (r = -0.413, p < 0.0001): i.e., the higher the VA at presentation, the smaller the gain. Comparison between 2010 and 2007 showed that in 2010, patients were older (82.2 ± 7.0 vs 78.3 ± 7.0 y, p < 0.0001), had a better baseline VA (60.6 ± 12.7 vs 56.1 ± 14.6 l, p = 0.0191) and, despite the reverse correlation between change in VA and VA at presentation, visual results were better: +6.0 ± 11.0 vs +0.7 ± 11.99 l, p = 0.0003. In 2010, eyes received more injections: 5.0 ± 1.8 vs 3.8 ± 1.4 in 2007, p < 0.0001. However, the series did not differ for the number of visits, gender, side or type of CNV. CONCLUSIONS: In 2010, monotherapy with ranibizumab for exudative AMD achieved better visual results than in 2007 in our clinical setting, despite the treatment of older patients with better baseline VA. This is probably due to the greater number of IVT performed. Alternate strategies, such as "inject and extend" or maintenance therapy, may also account for the better visual results.