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Background: To evaluate the incidence of posterior vitreous detachment (PVD) induced by intravitreal injection of different intravitreal drugs. Methods: This prospective observational study included 61 patients (61 eyes) with different underlying retinal diseases: exudative age-related macular degeneration ( n = 47), cystoid macular edema (CME) after retinal vein occlusion ( n = 8), and CME of other origin ( n = 6). Bevazicumab (1.25 mg) was injected into 25 eyes, ranibizumab (0.5 mg) into 27 eyes, triamcinolone (4 mg) into six eyes, and a combination of bevacizumab and triamcinolone into three eyes. Patients with initial PVD were excluded. Patients were followed for at least 4-6 weeks after their last injection by Fourier-domain OCT, fundus biomicroscopy and ultrasound B-examination. Results: Overall, 15 of 61 eyes developed a PVD after intravitreal injection ( n = 6 after ranibizumab, n = 7 after bevacizumab and n = 2 after triamcinolon) within a mean follow-up period of 11.1 weeks. PVD occurred in three eyes after the first injection, in three eyes after the second, and in seven eyes after the third injection. Incidence of PVD correlated with increasing age. Conclusion: Intravitreal injection of commonly-used drugs seems to induce posterior vitreous detachment, which may thus influence the outcome of the underlying disease. [ABSTRACT FROM AUTHOR]

. Purpose: The 'Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment study' (SPR study) is a randomized multicentre trial comparing primary vitrectomy (PV) and scleral buckling surgery (SB) for rhegmatogenous retinal detachment (RRD). This subanalysis was conducted to identify risk factors associated with anatomical outcomes. Methods: Relating the anatomical success results at the 1-year follow-up visit to pre- and intraoperative findings using multivariate statistical methods. Results: In the phakic subtrial, anatomical success was negatively associated with the number of breaks (p < 0.0001), break extension > 1 clock hour (p = 0.0005) and intraoperative use of cryotherapy (p = 0.0484). It was positively associated with retinal breaks with irregular edges (p = 0.0353) and subretinal fluid drainage (p = 0.0155). In the pseudophakic/aphakic subtrial, anatomical success was negatively associated with the number of retinal breaks (p = 0.0004) and previous YAG capsulotomy (p = 0.0256), and the combined effect of the surgical procedure and intraoperative use of laser (p = 0.0229). Conclusion: Primary anatomical success is an important result for patients undergoing RRD surgery. Our data demonstrate that the final anatomical outcome is related to a higher preoperative number of breaks and cryotherapy in phakic eyes. Additional risk factors varied between phakic and pseudophakic subgroups. Our findings may be used to facilitate the prognosis of future patients with RRD. [ABSTRACT FROM AUTHOR]

Purpose: To identify risk factors associated with best-corrected visual acuity (BCVA) 1 year after initial surgery following primary vitrectomy (PV) and scleral buckling surgery (SB) for rhegmatogenous retinal detachment (RRD). Methods: Relating the final BCVA at the 1-year follow-up visit to pre- and intraoperative findings in the 'randomized, prospective, multicenter clinical trial comparing scleral buckling versus primary vitrectomy for repair of rhegmatogenous retinal detachment' (SPR Study) using multivariate statistical methods. Results: In the phakic subtrial, final BCVA is associated with the number of breaks ( p = 0.0259), duration of symptoms ( p = 0.0476), baseline BCVA ( p = 0.0002), retinal detachment central to major vessels arcades ( p = 0.0088), total detachment ( p = 0.0027), and chain formation of breaks ( p = 0.0129). In the pseudophakic/aphakic subtrial, final BCVA is related to the number of retinal breaks ( p = 0.0010), secondary cataract or central capsular fibrosis ( p = 0.0141), intraoperative laser photocoagulation ( p = 0.0373), and inferior detachment with breaks below the 4 and 8 o'clock positions ( p = 0.0173). Conclusion: Final BCVA is the most important outcome for patients undergoing RRD surgery. Our results demonstrate that the final BCVA is related to a higher preoperative number of breaks in both subtrials. Additional risk factors varied between phakic and pseudophakic subgroups. [ABSTRACT FROM AUTHOR]

Background: Diabetes mellitus, as well as subsequent ocular complications such as cystoid macular edema (CME), are of fundametal socio-economic relevance. Therefore, we evaluated the influence of internal limiting membrane (ILM) removal on longterm morphological and functional outcome in patients with diabetes mellitus (DM) type 2 and chronic CME without evident vitreomacular traction. Method: Forty eyes with attached posterior hyaloid were included in this prospective trial and randomized intraoperatively. Prior focal ( n = 31) or panretinal ( n = 25) laser coagulation was permitted. Group I ( n = 19 patients) underwent surgical induction of posterior vitreous detachment (PVD), group II ( n = 20 patients) PVD and removal of the ILM. Eleven patients with detached posterior hyaloid (group III) were not randomized, and ILM removal was performed. One eye had to be excluded from further analysis. Examinations included ETDRS best-corrected visual acuity (BCVA), fluorescein angiography (FLA) and OCT at baseline, 3 and 6 months postoperatively. Main outcome measure was BCVA at 6 months, secondary was foveal thickness. Results: Mean BCVA over 6 months remained unchanged in 85% of patients of group II, and decreased in 53% of patients of group I. Results were not statistically significant different [group I: mean decrease log MAR 95% CI (0.06; 0.32), group II: (−0.02; 0.11)]. OCT revealed a significantly greater reduction of foveal thickness following PVD with ILM removal [group I: mean change: 95% CI (−208.95 μm; −78.05 μm), group II: (−80.90 μm: +59.17 μm)]. Conclusion: Vitrectomy, PVD with or without ILM removal does not improve vision in patients with DM type 2 and cystoid diabetic macular edema without evident vitreoretinal traction. ILM delamination shows improved morphological results, and appears to be beneficial in eyes with preexisting PVD. [ABSTRACT FROM AUTHOR]

After being exposed to a kindergarten teacher with infectious pulmonary tuberculosis, a 7-year-old girl with a positive tuberculin skin test was treated with isoniazid. 3 days after initiation of the tuberculostatic therapy, the girl was referred to our hospital with an acute onset of blurred vision. Visual acuity (VA) was 20/200 in both eyes. Examination revealed mild anterior chamber inflammation, optic disc swelling, cystoid macular edema and periphlebitis in both eyes. However, although active tuberculosis was ruled out, the interferon-gamma release assay was positive. The anti-tuberculosis therapy was intensified with pyrazinamide, isoniazid, rifampicin and methylprednisolone. Within 10 days we saw a resolution of the macular edema and VA was 20/25. The paradoxical worsening of the patient's condition after initiation of tuberculostatic therapy with isoniazid and the prompt response to systemic steroids are typical for Jarisch−Herxheimer reaction (JHR). Our patient presented no symptoms before the isoniazid therapy was started and the reaction was ocular without any generalized symptoms. This is unique among all other reported cases of ocular JHR. [ABSTRACT FROM AUTHOR]

Introduction: AURIGA is the largest real-world study to date to evaluate intravitreal aflibercept (IVT-AFL) in the treatment of diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion in routine clinical practice. The 24-month outcomes in the DME cohort from across 11 participating countries are reported here. Methods: AURIGA (NCT03161912) was a prospective observational study. The study enrolled eligible patients with DME for whom the decision to treat with IVT-AFL had previously been made by the attending physician. Patients were treated with IVT-AFL for up to 24 months at physician discretion according to local practice. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to month 12 (M12). All statistical analyses were descriptive. Results: In 1478 treatment-naïve and 384 previously treated patients with DME, the mean (95% confidence interval) change in VA from baseline was +6.7 (5.7, 7.6) and +7.4 (5.5, 9.4) letters by M12 and +5.9 (4.9, 6.9) and +8.1 (6.1, 10.1) letters by M24 (baseline [mean ± standard deviation]: 56.0 ± 19.8 and 50.8 ± 19.5 letters), respectively; 25.9% of treatment-naïve and 32.8% of previously treated patients achieved ≥ 15-letter gains by M24. The mean change in central retinal thickness from baseline to M24 was −110 (−119, −102) µm in treatment-naïve patients and −169 (−188, −151) µm in previously treated patients. By M6, M12, and M24, treatment-naïve patients had received 3.8 ± 1.7, 4.9 ± 2.8, and 5.7 ± 3.9 injections, respectively, and previously treated patients had received 3.9 ± 1.5, 4.9 ± 2.4, and 6.2 ± 3.6 injections, respectively. The safety profile of IVT-AFL was consistent with previous studies. Conclusion: In AURIGA, treatment-naïve and previously treated patients with DME achieved clinically relevant functional and anatomic improvements following IVT-AFL treatment for up to 24 months in routine clinical practice. Even with the decreasing injection frequency observed, these gains were largely maintained throughout the study, suggesting long-term durability of the positive effects of IVT-AFL treatment. Infographic available for this article. Trial Registration: ClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017). Infographic: [ABSTRACT FROM AUTHOR]

Purpose: To investigate the lower visual acuity threshold for recommending intravitreal injection therapy (IVI). The lower limit of 1.3 logMAR best-corrected visual acuity (BCVA) was adopted in 2006 and has been maintained since then. Methods: In this retrospective study, data from patients with a logMAR BCVA ≤ 1.3 and 24 months follow-up were analysed. We included patients with neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME), or retinal vein occlusion (RVO). Results: The data from 164 patients (nAMD: 107; DME: 15; RVO: 42) were analysed. We observed a significant improvement at all time intervals (0 to 6, 6 to 12, 12 to 18, and 18 to 24 months after initiating IVI) compared to baseline. Across all indications, median BCVA improved from 1.4 to 1.0 within the first 6 months and remained stable within 24 months. Patients received a median of 5 and 10 injections within 6 and 24 months, respectively. Median foveal retinal thickness was 594.5 μm at baseline and dropped to 244.5 μm, 235.5 µm, 183 µm, and 180 µm during the four consecutive time intervals. Conclusion: Patients with nAMD, DME, and RVO with poor baseline BCVA may also benefit from intravitreal therapy with VEGF-inhibitors. In the present study, we observed functional and morphological improvement over 2 years irrespective of the underlying macular disease. Those patients should not be excluded from therapy. [ABSTRACT FROM AUTHOR]

In vitro primary cell culture models of retinal ganglion cells (RGC) are widely used to study pathomechanisms of diseases such as glaucoma. The biomechanic interaction with the culture substrate is known to influence core cellular functions. RGC cultures, however, are usually grown on rigid plastic or glass substrates. We hypothesized that soft polyacrylamide gel substrates may alter survival and neurite outgrowth of primary cultured RGC. Primary retinal cultures from postnatal (day 1–6) Wistar rats were grown on glass coverslips or polyacrylamide (PA) gel substrate with different Young's elastic moduli (0.75, 10 or 30 kPa). Substrates were coated with Poly-l-lysine and/or laminin. RGC were immunostained with anti-beta-III-tubulin. Total neurite length, growth cone morphology, RGC density, mitochondrial morphology and transport as well as pro-survival pathways (Erk1/2, Akt, CREB) were assessed. PA gel substrates of E = 10 kPa significantly increased the total neurite length by factor 1.5 compared to glass (p = 0.02). The growth cone area was significantly larger by factor 5.3 on 30 kPa gels (p = 0.01). The presence of a substrate coating was more important for neurite outgrowth and RGC survival on PA gels (poly-l-lysine > laminin) than on glass. Neither mitochondrial morphology and motility nor the activation of pro-survival pathways significantly differed between the four substrates. PA gel substrates significantly enhanced RGC neurite outgrowth. The signaling cascades mediating this effect remain to be determined. • Polyacrylamide gels were used as substrate for primary retinal ganglion cell culture. • Gels of 10 kPa significantly enhanced neurite outgrowth compared to glass. • Higher gel stiffness positively correlated with the neurite growth cone size. • Poly-l-lysine coating was an important mediator of this effect. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the influences and risk factors for severe bleeding complications during glaucoma surgery, and to investigate the role of antiplatelet (AP) and anticoagulant (AC) agents. Methods: This prospective study enrolled patients undergoing trabeculectomy, trabeculotomy (with Trabectome® or Kahook Dual Blade®), viscocanaloplasty and Ahmed or Baerveldt implants. Bleeding severity was graded on an ordinal scale ranging from 0 to 5. Immediately after surgery and one day later, the incidence and severity of bleeding events was documented on a standardized form. A grade ≥ 3 was defined as severe bleeding. The influence of known systemic disorders, the type of anesthesia, surgical procedure, intraoperative blood pressure, and the use of or change in AP or AC agents on intraoperative bleeding were analyzed. Results: Data from 89 eyes undergoing glaucoma procedures were included (age 71.3y ± 10.5). We observed severe intraoperative bleeding in 8 eyes (9%) and found that concomitant diseases such as the history of a deep vein thrombosis or peripheral arterial occlusive disease, and the type of surgical procedure (trabeculectomy and viscocanaloplasty) were significantly associated with severe bleeding events. By contrast, the use of AP/ AC agents had no significant influence on severe intraoperative bleeding events. Conclusion: According to the results of our study cohort, glaucoma procedures entailing scleral manipulations (trabeculectomy and viscocanaloplasty) and concomitant diseases such as the history of a deep vein thrombosis or peripheral arterial occlusive disease influence the risk of severe intraoperative bleeding events, we detected no increased risk related to concomitant antiplatelet and/ or anticoagulant medication use. [ABSTRACT FROM AUTHOR]

Purpose: To correlate functional and morphological parameters with foveal avascular zone's (FAZ) size in diabetic patients with mild to moderate stage nonproliferative diabetic retinopathy. Methods: Monocentric and prospective study of a consecutive case series of diabetic patients. Medical history, best corrected visual acuity (BCVA), best corrected high/low contrast visual acuity (BChcVA/BClcVA), mean sensitivity (MS) and mean defect (MD) in central visual field testing, and FAZ size in fluorescein-angiography (FAG) were recorded. Macular thickness (central point thickness CPT, central subfield thickness CST) and volume measurements (central subfield volume CSV, total macular volume) were taken from SD-OCT (6x6mm ETDRS-grid). Groups were categorised as presenting FAZ sizes smaller (G1) or larger (G2) than 0.35mm2. Smallest (Q1) and largest quartiles (Q3) were also compared. Results: Thirty-six of 40 patients were included. MS differed significantly between G1 (n = 6) and G2 (n = 30), and BChcVA/BClcVA as well as TMV correlated significantly with FAZ size in correlation analysis. Mean HbA1c tended to be lower in G1 than G2. Patients in G1 were slightly older than in G2. Treatment period with insulin was shorter in G1/Q1 than in G2/Q3. CPT and TMV were lower in G1/Q1 than in G2/Q3. Our analysis of the FAZ in terms of patient age, HbA1c, disease duration and insulin therapy duration revealed no significance. That lack of significance also applies to BCVA, MS, MD, CPT, CST and CSV. Conclusion: As significantly associated, contrast sensitivity, central visual field parameters and potentially retinal thickness or volume seem to be suitable to detect early macular ischaemia. However, we failed to establish any correlation between FAZ and BCVA. [ABSTRACT FROM AUTHOR]

Neovascular age-related macular degeneration (nAMD) is a progressive retinal disease that often leads to severe and permanent vision loss. Early initiation of anti-vascular endothelial growth factor (anti-VEGF) therapy has been shown to preserve vision in nAMD patients. Concurrently, treatment outcomes in real-world are inferior to those reported in clinical trials. The most likely reasons observed are fewer treatment-intensity in routine clinical practice than in clinical trials. The other possibility could be the delay in starting treatment and the re-treatment interval. Although a negative impact of aforementioned parameters seems obvious, quantitative impact measures remain elusive in a real-world setting due to a lack of an 'optimal treatment' control group. To overcome this shortcoming, we developed, validated, and applied a model to assess and quantify the impact of anti-VEGF administration variables on visual acuity development in a prospective nAMD patient cohort. The model was further applied to probe the impact of the COVID-19 pandemic on visual progressions in nAMD patients. The presented model paves the way to systematically explore and evaluate realistic interventions in the current treatment paradigm, that can be adopted in routine clinical care. [ABSTRACT FROM AUTHOR]

Purpose: The goal of this study was to analyze the incidence of perioperative bleeding complications in rhegmatogenous retinal detachment. The handling of perioperative anticoagulation during vitreoretinal surgery remains controversial, since the risk of bleeding complications by its continuation has to be balanced against the risk of progression of retinal detachment and the risk of thromboembolic events when anticoagulation is interrupted. Nevertheless, only few studies have investigated the risk of perioperative bleeding complications in an emergency such as retinal detachment surgery. Methods: We therefore examined the rate of all perioperative hemorrhages and separately the rate of only severe bleedings during vitrectomy, scleral buckling with or without drainage of subretinal fluid (SRD), or combined procedures due to retinal detachment in patients undergoing different types of perioperative anticoagulation including acetylsalicylic acetate (ASA), clopidogrel, heparin, low molecular weight heparin, and phenprocoumon. Results: This retrospective single-center study included 893 patients with primary rhegmatogenous retinal detachment, n = 192 on anticoagulation and n = 701 serving as control without anticoagulation. Our analysis revealed no significantly increased rate of perioperative hemorrhages under anticoagulation with ASA 100 mg (all, 11.4%; severe, 5.0%) or phenprocoumon (all, 11.6%; severe, 2.3%) compared with controls (all, 13.0%; severe, 5.4%). However, frequencies of bleeding complications varied markedly regarding the type of surgical procedure: Scleral buckling plus SRD showed the highest rates of hemorrhages (all, 18.9%; severe, 9.1%) with significant difference (P < 0.001) compared with scleral buckling without SRD (all, 3.8%; severe, 0.6%) and vitrectomy (all, 9.2%; severe, 1.5%), respectively. Furthermore, subretinal bleeding was the most common type of perioperative hemorrhage. Conclusions: The data suggest not to stop ASA therapy prior to vitreoretinal surgery. Furthermore, we found no evidence of an increased risk for perioperative bleedings in patients under anticoagulation with vitamin-k antagonists with an INR within the sub-therapeutic range. SRD during scleral buckling procedure should be avoided as possible and regardless of any type of anticoagulation. [ABSTRACT FROM AUTHOR]

Background: The objective of the study was the investigation of the effects of intravitreal bevacizumab (BEV) with or without additional macular grid laser photocoagulation (GRID) for macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Methods: Prospective, randomized, monocentric study. Thirty-two patients were included. Initially, all eyes in both groups received three monthly injections of BEV, followed by additional injections if re-treatment criteria were met. In the BEV + GRID group, photocoagulation was performed 2 weeks after the first BEV injection and laser re-treatment was allowed. The follow-up was 38 weeks. Main outcome measures were best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Changes of foveal avascular zone (FAZ) and of retinal ischemia, as well as the number of injections were also evaluated. Results: Sixteen eyes were randomized into each group. At baseline, BCVA was similar in both groups (BEV + GRID: 20/71; BEV: 20/60; P = 0.51). At 38 weeks, BCVA significantly improved in the two groups (BEV + GRID gain of 9 ± 11.2 letters and 16.25 ± 10.08 letters in the BEV) with no difference between them (P < 0.06). With regard to anatomical findings, initial CRT in BEV + GRID was 496.2 μm ± 138.4 μm and 538.9 μm ± 156.9 μm in BEV (P < 0.1697). At 38 weeks, CRT decreased in both groups significantly, 98.2 μm in the BEV + GRID (P = 0.02) and 141.7 μm in the BEV group (P = 0.01), with no significant difference between groups (P < 0.17). The area of FAZ a significantly increased in both groups (41% (P = 0.04) in BEV + GRID; 35% (P = 0.03) in BEV) during the study and the grade of peripheral ischemia remained unchanged. The mean number of injections was 3.8 (range 3–6) with no significant difference between groups. Conclusions: Our data demonstrate a beneficial effect of bevacizumab in ME in eyes with BRVO. A loading phase of three injections led to a significant improvement in vision in both groups, which persisted at week 38. Additional grid laser photocoagulation exhibited no beneficial functional or anatomical effect during the study, nor did it reduce the number of injections. The FAZ area increased significantly in both groups, but overall retinal ischemia did not. Further studies investigating more numerous eyes and longer follow-up are needed to confirm these data. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To compare the efficacy and safety of ranibizumab 0.5 mg versus dexamethasone 0.7 mg according to their European labels in macular oedema secondary to branch retinal vein occlusion (BRVO) in a 6‐month, phase IIIb, randomized trial. Methods: Patients received either monthly ranibizumab for 3 months followed by Pro re nata (PRN) treatment (n = 126) or a sustained‐release dexamethasone implant followed by PRN sham injections (n = 118). Main outcomes were mean average change in best‐corrected visual acuity (BCVA) from baseline to month 1 through month 6, mean changes in BCVA and foveal centre point thickness (FCPT), and adverse events (AEs). Results: There was no difference in BCVA gains between the treatments prior to month 3. Best‐corrected visual acuity (BCVA) gain with dexamethasone declined thereafter. From month 3 to month 6, mean BCVA change from baseline was significantly higher with ranibizumab than with dexamethasone [raw means (standard deviation):+16.2 (±11) letters versus +9.3 (±10.1) letters]. At month 6, the difference in BCVA gains from baseline was +17.3 letters in the ranibizumab versus +9.2 letters in the dexamethasone group. Patients in the ranibizumab group received a mean of 2.94 loading injections and 1.74 PRN retreatment injections, while those in the dexamethasone group received a single loading injection. Elevated intraocular pressure (IOP) and AEs were more frequent with dexamethasone than ranibizumab treatment. Conclusion: Ranibizumab PRN resulted in greater visual acuity (VA) gains in macular oedema following BRVO compared with single‐dose dexamethasone over a 6‐month study period, observed from month 3, when administered according to their European label. In clinical practice, retreatment with dexamethasone may be required prior to this point. [ABSTRACT FROM AUTHOR]

Purpose: To identify factors that may lead to a rapid progression in macula-on rhegmatogenous retinal detachment (RRD), in particular, those that may lead to macular involvement. Methods: Observational, prospective, single-center study. Patients referred for surgery due to primary rhegmatogenous retinal detachment with the macula on between 2009 and 2013 were included. Relevant factors analyzed included age, time delay until surgery, lens status, myopia, the detachment's location and configuration as well as number, size and type of retinal breaks. Eyes underwent optical coherence tomography to detect macular detachment. A multivariate analysis was performed to investigate the effect of several factors in the progression of retinal detachment. Results: A total of 116 eyes of 116 patients were included. Mean time delay between admission and surgery was 1.8 ± 1.4 days. Progression was observed in 19.8% of the eyes. Of those, 47.8% presented macular detachment. Ten of the 11 (90.9%) eyes presenting progression involving the macula also exhibited a bullous configuration, which was the only parameter that correlated significantly with detachment progression in patients with ( p = 0.0036) and without ( p = 0.0014) macular involvement. Conclusions: For the first time in a prospective trial, a bullous configuration was found to be a highly significant predictor for progression in macula-on detachments. Our data support prompt surgery in patients diagnosed with bullous macula-on RRD. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate prospectively the efficacy and safety of a fixed bimonthly ranibizumab treatment regimen (RABIMO) in eyes with neovascular age-related macular degeneration (nAMD) and to compare these results with a pro re nata (PRN) treatment scheme. Methods: This was a 12-month, phase IV, single center, randomised, non-inferiority study. Following three initial monthly injections, patients were randomised to receive either ranibizumab bimonthly (RABIMO group) or ranibizumab PRN (PRN group) ( n = 20 each). Main outcome measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), number of injections, and adverse events (AEs). Results: BCVA [median (interquartile range, IQR)] increased significantly in both groups after 12 months [RABIMO group +8.5 (14); PRN group +6.5 (16) ETDRS letters] when compared to baseline ( p < 0.0001; p = 0.0085). At month 12, the RABIMO treatment regimen was non-inferior to the PRN scheme (∆BCVA = 3.5 ETDRS letters; p < 0.0001). CRT was significantly reduced in both groups after the 12-month study period ( p < 0.0001 each), with no significant difference between groups ( p = 0.6772). Number of overall injections [median (IQR)] was 8 (0) in the RABIMO versus 4 (5) in the PRN group ( p = 0.0037). Three patients in the RABIMO group received one additional unscheduled injection. We observed no significant differences between groups in the number of patients with reported SAEs/AEs (RABIMO group n = 6/15; PRN group n = 7/13) ( p = 0.7357/ p = 0.4902). Conclusions: We found no evidence of significant functional or anatomical differences between the RABIMO and PRN treatment regimens. However, the RABIMO group's number of injections was twice as high as the PRN group's (protocol-driven). In light of potential side effects, the fixed bimonthly treatment regimen might not be advisable for routine clinical care, but it might be a worthwhile treatment option if monthly monitoring is not possible. Eudra-CT number: 2009-017324-11. [ABSTRACT FROM AUTHOR]