The Optical Coherence Tomography and Microperimetry Biomarker Evaluation in Patients with Geographic Atrophy (OMEGA) Study: Design and Baseline Characteristics - OMEGA Report 1.

INTRODUCTION: The aim of this study was to describe the design and the participants' baseline characteristics of a prospective natural history study of geographic atrophy (GA) secondary to age-related macular degeneration. METHODS: The optical coherence tomography (OCT) and microperimetry biomarker evaluation in patients with GA (OMEGA) study was conducted at a tertiary referral center (ClinicalTrials.gov identifier: NCT05963646). Participants were followed for 12 months during 4 visits (baseline and follow-up exams at weeks 12, 24, and 48) with best-corrected Early Treatment of Diabetic Retinopathy Study visual acuity, low-luminance visual acuity (LLVA), and quick contrast sensitivity function testing. Further, participants underwent spectral-domain OCT, OCT angiography, fundus autofluorescence imaging, and mesopic microperimetry testing. RESULTS: Thirty participants (median [IQR] age of 79 [77, 84] years) and 37 study eyes were included with a (median [IQR]) GA area of 1.40 mm2 (0.49, 5.24) at baseline. Out of 37 study eyes, six developed macular neovascularizations (16%). The study-eye best-corrected visual acuity was (median [IQR]) 0.18 logarithm of the minimum angle of resolution (logMAR) (0.06, 0.26), LLVA 0.66 logMAR (0.36, 0.88), and the microperimetry mean sensitivity 18.4 dB (9.21, 20.9). The highest correlation between square root GA area and a visual function test was evident for LLVA (R2 of 0.578), followed by area under the log contrast sensitivity function curve (0.519) and microperimetral retinal sensitivity (0.487). CONCLUSION: This report lays out the design and baseline characteristics of the OMEGA study, which aims to contribute to the understanding of the natural history of GA. The OMEGA study will provide estimates of the ability to detect change and retest reliability for a panel of structure and functional assessments.

Predictors for 2-Year Functional and Morphological Outcomes of a Treat-and-Extend Regimen with Ranibizumab in Patients with Diabetic Macular Edema.

PURPOSE: The purpose of the study was to investigate longer term functional and morphological outcomes and their predictors in diabetic macular edema (DME) following a treat-and-extend regimen (TER) without loading dose under ranibizumab. METHODS: Patient data were reviewed and analyzed retrospectively over a period of 24 months after initiation of TER. Best-corrected visual acuity (BCVA), treatment frequency, and quantitative and qualitative spectral-domain optical coherence tomography parameters were assessed. RESULTS: 118 eyes of 87 patients were included. A mean of 9.74 ± 2.13 injections in the first and 7.63 ± 2.29 in the second year were applied. There were significant gains of BCVA and reductions in central retinal thickness from baseline to 12 and 24 months (all p < 0.001). Percentage of eyes with an intact inner segment/outer segment (IS/OS) junction increased from 15.3% at baseline to 42.1% at 24 months (p < 0.001). An intact IS/OS junction at baseline increased the probability of having a dry retina after 12 months by 79.3% (p = 0.017) and after 24 months by 88.1% (p = 0.040). Less IS/OS disruption at baseline predicted longer maximum recurrence-free treatment intervals at 2 years (r = -0.345, p < 0.001) and better BCVA at 1 year (r = -0.347, p < 0.001). Baseline bigger intraretinal cysts were associated with more IS/OS disruption at 24 months (r = 0.305, p = 0.007). Younger age and lower BCVA at baseline were predictive for a higher BCVA gain at 24 months (p = 0.046, p < 0.001). CONCLUSION: Ranibizumab applied in a TER without loading dose in DME significantly improves visual acuity and retinal anatomical structure throughout 2 years. The evaluated predictors might help guide routine clinical treatment in DME.

ASSESSMENT OF DRUSEN AND OTHER RETINAL DEGENERATIVE CHANGES IN PATIENTS WITH HEREDITARY HEMOCHROMATOSIS.

PURPOSE: Iron can exert oxidative damage, and increased accumulation is believed to play a role in age-related macular degeneration. Hereditary hemochromatosis leads to an increase in total body iron. Patients with HH were assessed for drusen and other retinal changes. METHODS: Descriptive uncontrolled study of spectral-domain optical coherence tomography, short-wavelength autofluorescence, and color fundus images from patients with HH were used. Diagnosis of HH was established by measuring ferritin and transferrin saturation, and confirmed by genetic testing. Classification of the patients according to initial ferritin level was: Group A >1,032 µg/L; Group B below. RESULTS: Twenty-five percent of the invited participants were enrolled. Mean age at diagnosis was 46 ± 15 years in Group A, and 38 ± 13 years in Group B, P = 0.07, whereas mean age at imaging was 60 ± 13 years in Group A, and 48 ± 15 years in Group B (P = 0.003). The median of the initial ferritin level was 1,869 (1,262-3,256) ng/mL in Group A, and 534 (439-679) ng/mL in Group B. No subject in either group revealed multiple drusen, unambiguous changes of the retinal pigment epithelium, or increased lipofuscin in any of the images. CONCLUSION: The study results did not show an increased prevalence of drusen or other retinal degenerative changes in patients with HH. Thus, it was concluded that increased intestinal iron absorption as well as increased blood iron concentration are not risk factors for the early development of retinal degenerative changes in this study population.

INTRAVITREAL AFLIBERCEPT IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION WITH LIMITED RESPONSE TO RANIBIZUMAB: A Treat-and-Extend Trial.

PURPOSE: To evaluate aflibercept treat-and-extend regimen for treatment of neovascular age-related macular degeneration in patients with limited response to ranibizumab. METHODS: This prospective single-arm trial included 33 patients with neovascular age-related macular degeneration pretreated with treat-and-extend regimen ranibizumab for ≥6 months who failed to be extended to a 6-week interval at least twice. All patients received aflibercept (2 mg/0.05 mL) at baseline, and were subsequently treated according to treat-and-extend regimen, starting with a 4-week interval and extending in 2-week steps. Evaluations included mean maximum recurrence-free treatment interval; best-corrected visual acuity; central retinal thickness; and pigment epithelium detachment height and horizontal diameter. RESULTS: At Week 24, the maximum recurrence-free treatment interval increased to ≥6 weeks in ∼35% of patients, whereas the mean interval was 4.9 ± 1.3 weeks. Best-corrected visual acuity score remained stable, but significant reductions in central retinal thickness (P < 0.001) and pigment epithelium detachment height (P = 0.001) were observed compared with baseline, as was a small decrease in horizontal pigment epithelium detachment diameter (P = 0.035). CONCLUSION: After switching patients with limited ranibizumab response to aflibercept, signs of choroidal neovascularization activity regressed, and an increased duration of treatment effects was seen in approximately one-third of lesions, but visual acuity was unchanged.

Baseline Optical Coherence Tomography Findings as Outcome Predictors after Switching from Ranibizumab to Aflibercept in Neovascular Age-Related Macular Degeneration following a Treat-and-Extend Regimen.

PURPOSE: To evaluate outcome predictors of aflibercept in neovascular age-related macular degeneration pretreated with ranibizumab based on a treat-and-extend regimen (TER). METHODS: We performed a retrospective evaluation of 18-month follow-up of 45 consecutive patients with limited response to ranibizumab. RESULTS: At month 18, mean central retinal thickness and intraretinal fluid (IRF) height were significantly reduced. The recurrence-free treatment interval (RFTI) increased from 7.0 ± 1.8 to 8.5 ± 2.4 weeks (p = 0.01); visual acuity remained stable. At month 18, 58.1% of patients showed a longer RFTI. At month 12, eyes with baseline subretinal fluid (SRF) had a shorter RFTI than those without SRF (p = 0.032). Eyes with baseline IRF showed a longer RFTI than those without IRF (p = 0.037). Baseline hyperreflective foci (HRF) presence indicated improvement in SRF (p = 0.024) and IRF at month 12 (p = 0.049). CONCLUSION: Baseline HRF presence predicted better morphological outcome, while SRF predicted a shorter RFTI and IRF a longer RFTI after switching from ranibizumab to aflibercept within a TER.

Ranibizumab plus verteporfin photodynamic therapy in neovascular age-related macular degeneration: 12 months of retreatment and vision outcomes from a randomized study.

PURPOSE: To investigate the injection frequency and visual acuity (VA) outcomes with combination therapy (ranibizumab plus verteporfin photodynamic therapy, PDT) versus monotherapy (ranibizumab). METHODS: A total of 40 patients with exudative age-related macular degeneration were randomized 1:1 to ranibizumab 0.3 mg plus single standard verteporfin PDT or ranibizumab 0.3 mg plus sham PDT. Ranibizumab was administered 3 times monthly followed by 'as needed' to month 12 based on predetermined vision/anatomical criteria. Retreatment rates, VA outcomes and safety were assessed. RESULTS: During months 3-12, combination therapy patients required fewer ranibizumab injections (mean 1.3) compared with monotherapy patients (2.8). Mean VA improved by 9.0 letters with combination therapy versus 7.5 letters in the monotherapy group at month 12. Both treatment regimens were well tolerated. CONCLUSION: The need for ranibizumab retreatment might be reduced by administering a single verteporfin PDT on the same day as the first ranibizumab injection, without compromising VA outcomes or safety.

Relaxing radial retinal incisions for the treatment of persistent macular holes.

PURPOSE: Various surgical techniques have been described for managing persistent macular holes after an unsuccessful vitrectomy with internal limiting membrane (ILM) peeling. However, the closure and functional improvement rates after these procedures are limited. Therefore, the aim of this study was to evaluate the usefulness of radial retinal incisions (retinotomies) in eyes with persistent large macula holes despite previous vitrectomy with ILM peeling. DESIGN: In a retrospective case series, closure rate and best-corrected visual acuity (BCVA) were evaluated in eyes with persistent macular holes after an unsuccessful vitrectomy that included posterior vitreous detachment and ILM peeling. SUBJECTS: 22 eyes of 22 patients (10 men and 12 women) underwent re-vitrectomy with radial retinal incisions. All the patients had undergone an unsuccessful surgery before. METHODS: Small-incision re-vitrectomy with radial retinal incisions (retinotomies) and air tamponade was performed. MAIN OUTCOME MEASUREMENTS: For all eyes, high-definition SD-OCT scans (SD-OCT Spectralis, Heidelberg Engineering GmbH, Germany) of the macula were routinely performed before surgery; 1 week and 1 month after surgery; and at final follow-up. Additionally, age, gender, axial length, macular hole diameter, biomicroscopic fundus evaluation and best-corrected visual acuity (BCVA) in logMAR and Snellen at baseline, 1 and 4 months after operation, and at the final follow-up visit were analyzed. RESULTS: The mean baseline macular hole diameter was 668.5 ± 226.8 µm. At the final examination, 16 (72.72%) of the 22 macula holes were closed. Visual acuity increased in 17 eyes, was stable in 3 eyes, and decreased in 2 eyes owing to central retinal atrophy in both. The mean BCVA increased from logMAR 1.04 ± 0.29 at baseline to 0.57 ± 0.31 (Snellen 0.11 ± 0.05 to 0.33 ± 0.18). In all successful cases, macula hole closure was attained after 3 days, and none of the eyes showed macula hole recurrence. CONCLUSION: The results of this limited case series suggest that radial retinal incisions of the rim in persistent macula holes after initial surgery with ILM peeling increase the success rate of macula hole closure and results in a relevant increase in BCVA. However, as the number of eyes included in this series is limited, the results must be confirmed in a study with a larger sample size.

Autologous internal limiting membrane transplantation achieves anatomic closure and functional improvement in the treatment of large, persistent macular holes.

PURPOSE: To evaluate the clinical outcome of subretinal autologous internal limiting membrane (ILM) transplantation during pars-plana vitrectomy for persistent full-thickness macular hole (FTMH) repair. METHODS: Retrospective, consecutive case series of 13 eyes (13 patients) undergoing small-incision vitrectomy with ILM transplantation and air tamponade for large persistent FTMH after prior unsuccessful vitrectomy with posterior hyaloid detachment and ILM peeling. MAIN OUTCOME MEASUREMENTS: For all eyes, high-definition spectral domain optical coherence tomography scans (SD-OCT Spectralis, Heidelberg Engineering GmbH, Germany) of the macula were routinely performed before surgery, 1 and 4 weeks after surgery, and at the final follow-up visit. Additionally, age, gender, axial length, macular hole diameter, biomicroscopic fundus evaluation and best-corrected visual acuity (BCVA) at baseline, 1 and 4 weeks after surgery, and at the final follow-up visit were analyzed. RESULTS: Anatomic closure was achieved in all 13 cases (100% success rate). Closure pattern was classified in accordance with to Rossi et al. (Graefe's Arch Clin Exp Ophthalmol 258(12):2629-2638, 2020). Mean baseline BCVA logMAR was 0.93, mean postoperative BCVA logMAR was 0.66 with a mean postoperative follow-up period of 11.4 months. No re-opening occurred during the observation period. CONCLUSIONS: Placing an autologous ILM-transplant in the subretinal space beneath the margin of the FTMH can support anatomic restauration and functional improvement in large, persistent FTMHs.

Brolucizumab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: Ophthalmology and Diabetology Treatment Aspects.

Anti-vascular endothelial growth factor (anti-VEGF) therapies have become the standard of care in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), resulting in a remarkable decrease in disease-related vision loss. However, the need for regular injections places a significant burden on patients, caregivers, and the healthcare system and improvements in vision may not be maintained long term. As a result of its drying potency and duration of action, brolucizumab, an intravitreal anti-VEGF therapy approved for the treatment of nAMD and DME, could decrease injection frequency for patients and provide an efficacious treatment; however, balancing its benefits and risks can be challenging. There have been reports of intraocular inflammation (IOI) in patients treated with brolucizumab, which, if left untreated, may result in severe vision loss. Recent evidence, however, indicates that early recognition of IOI and prompt and aggressive systemic corticosteroid treatment in response to posterior segment involvement can lead to favorable outcomes in these relatively rare but severe cases. A series of consensus meetings were conducted in 2022 between Swiss medical retina experts and diabetologists, discussing the current data for brolucizumab and exploring various challenges to its use, including the associated risk of IOI. The outcome is a collation of practical insights and guidance for ophthalmologists on the use of brolucizumab in patients with nAMD and DME, including patient selection and assessment, treatment regimen and monitoring, and the recognition and management of adverse events.

A systematic comparison of spectral-domain optical coherence tomography and fundus autofluorescence in patients with geographic atrophy.

PURPOSE: To evaluate spectral-domain optical coherence tomography (SD-OCT) in providing reliable and reproducible parameters for grading geographic atrophy (GA) compared with fundus autofluorescence (FAF) images acquired by confocal scanning laser ophthalmoscopy (cSLO). DESIGN: Prospective observational study. PARTICIPANTS: A total of 81 eyes of 42 patients with GA. METHODS: Patients with atrophic age-related macular degeneration (AMD) were enrolled on the basis of total GA lesion size ranging from 0.5 to 7 disc areas and best-corrected visual acuity of at least 20/200. A novel combined cSLO-SD-OCT system (Spectralis HRA-OCT, Heidelberg Engineering, Heidelberg, Germany) was used to grade foveal involvement and to manually measure disease extent at the level of the outer neurosensory layers and retinal pigment epithelium (RPE) at the site of GA lesions. Two readers of the Vienna Reading Center graded all obtained volume stacks (20×20 degrees), and the results were correlated to FAF. MAIN OUTCOME MEASURES: Choroidal signal enhancements and alterations of the RPE, external limiting membrane (ELM), and outer plexiform layer by SD-OCT. These parameters were compared with the lesion measured with severely decreased FAF. RESULTS: Foveal involvement or sparing was definitely identified in 75 of 81 eyes based on SD-OCT by both graders (inter-grader agreement: κ=0.6, P < 0.01). In FAF, inter-grader agreement regarding foveal involvement was lower (48/81 eyes, inter-grader agreement: κ=0.3, P < 0.01). Severely decreased FAF was measured over a mean area of 8.97 mm(2) for grader 1 (G1) and 9.54 mm(2) for grader 2 (G2), consistent with the mean SD-OCT quantification of the sub-RPE choroidal signal enhancement (8.9 mm(2) [G1] -9.4 mm(2) [G2]) and ELM loss with 8.7 mm(2) (G1) -10.2 mm(2) (G2). In contrast, complete morphologic absence of the RPE layer by SD-OCT was significantly smaller than the GA size in FAF (R(2)=0.400). Inter-reader agreement was highest regarding complete choroidal signal enhancement (0.98) and ELM loss (0.98). CONCLUSIONS: Absence of FAF in GA lesions is consistent with morphologic RPE loss or advanced RPE disruption and is associated with alterations of the outer retinal layers as identified by SD-OCT. Lesion size is precisely determinable by SD-OCT, and foveal involvement is more accurate by SD-OCT than by FAF.

Retinal thickness and volume measurements in diabetic macular edema: a comparison of four optical coherence tomography systems.

PURPOSE: To compare different spectral domain optical coherence tomography devices regarding retinal thickness values in patients with diabetic macular edema and to correlate the results with conventional time domain Stratus OCT data. METHODS: Thirty eyes of 30 consecutive patients with diabetic macular edema were included into a prospective study. The macula was examined by Spectralis HRA+OCT, Cirrus HD-OCT, 3D OCT-1000, and Stratus OCT. The procedures' sequence was performed by a single experienced technician in a randomized fashion according to a computer-generated list. In each eye, foveal thickness, foveal volume, and total macular volume were measured automatically. Intraclass correlation, coefficients of variance, and coefficients of repeatability were calculated. RESULTS: Foveal thickness differed between the particular devices with a mean ± SD ranging from 359.97 ± 105.84 µm to 437.70 ± 115.84 µm. Correlation between the different OCT devices resulted in r > 0.7 (Pearson), and intraclass correlation was >0.9. Agreement of measurements was assessed showing a mean difference of foveal thickness values ranging from 19.2 µm to 77.7 µm (P < 0.05) and coefficients of repeatability ranging from 37.7 µm to 87.4 µm. CONCLUSION: While intradevice reproducibility is satisfactory, retinal thickness and volume measurements should not be used interchangeably because measurements differed significantly between systems. The lack of interdevice agreement seems to be related to the different segmentation algorithm of thickness measurement and should be considered because it may strongly influence treatment decisions and conclusions.

Pre-Descemetic Placement of Intracorneal Ring Segments for Keratoconus after Mechanical Implantation.

We report the case of a 23-year-old male who was referred to our clinic for a routine follow-up examination. The patient was treated for keratoconus 3 years ago in Colombia, where intracorneal ring segments were implanted mechanically in both eyes to improve his visual acuity. Surprisingly, we discovered a pre-descemetic placement of intracorneal ring segments, which could lead to potential complications, under circumstances. We illustrate this impressive finding with slit-lamp photography and high-resolution anterior segment OCT and advocate for the use of femtosecond laser as the method of choice for intracorneal ring segment insertion in order to provide maximal precision and safety.

In vivo retinal morphology after grid laser treatment in diabetic macular edema.

PURPOSE: To analyze immediate in vivo intraretinal morphologic changes secondary to standardized grid photocoagulation using spectral domain optical coherence tomography (SD OCT). DESIGN: Prospective clinical trial. PARTICIPANTS: Thirteen consecutive patients with treatment-naïve clinically significant diabetic macular edema (DME). METHODS: Before and 1 day after standardized grid photocoagulation using the PASCAL system (Pattern Scan Laser, OptiMedica Corporation, Santa Clara, CA), Spectralis OCT (Heidelberg Engineering, Heidelberg, Germany) examinations based on an eye-tracking system, infrared fundus imaging, color fundus photography, and biomicroscopy were performed. A standardized visual acuity assessment (Early Treatment Diabetic Retinopathy Study protocol) and fluorescein angiography were performed at baseline. MAIN OUTCOME MEASURES: Morphologic changes secondary to grid laser treatment. RESULTS: One day after laser therapy, immediate morphologic alterations of only the outer retinal layers, that is, the retinal pigment epithelium (RPE), the photoreceptor layer (PRL), and the outer nuclear layer (ONL), were observed. The shape of the laser-induced lesions did not show a sagittal alteration pattern throughout all 3 of the layers, however, but rather seemed to follow an oblique pathway throughout the ONL, changing direction at the level of the external limiting membrane and proceeding sagittally through the PRL and RPE. These morphologic changes also induced biometric changes, such as a decrease in central retinal thickness combined with local thickening at the lesion site, especially in the PRL. CONCLUSIONS: Spectral domain optical coherence tomography provides new insight into the immediate morphologic changes after laser treatment using the PASCAL laser system. Standardized grid photocoagulation induces characteristic homogenous alteration in the neurosensoric retinal layers. Biometric changes, indicating an immediate effect, were observed within 1 day after treatment.

Intraindividual comparison of color perception and contrast sensitivity with and without a blue light-filtering intraocular lens.

PURPOSE: To investigate color perception and contrast sensitivity with and without additional glare in pseudophakic patients with a conventional intraocular lens (IOL) in one eye and a blue light-filtering IOL in the fellow eye. METHODS: Twenty-three bilaterally pseudophakic patients with a conventional IOL (AcrySof SA60AT) and a blue light-filtering IOL (AcrySof Natural SN60AT) were tested for intraindividual comparison of visual acuity (ETDRS chart), color perception (Farnsworth-Munsell 100-Hue test), and contrast sensitivity with and without glare (Contrast Sensitivity Pattern Generator). Information about subjective perception was gathered through a questionnaire. RESULTS: Four patients (17.4%) observed some difference in monocular color perception. Color testing did not show significantly different results for the two IOL types expressed as total error score and segmental error subscores for protan, deutan, and tritan ranges. Regarding contrast sensitivity, 5 patients (21.7%) indicated noticeable difference between the two eyes. Contrast sensitivity testing, however, showed similar curves for the two IOL types with and without additional glare. CONCLUSIONS: Despite some subjective difference in color and contrast perception in a minority of patients, the study did not show significantly different results for the two IOL types.

Low-Energy Stereotactic Radiotherapy for Treatment of Exudative Age-Related Macular Degeneration in a Treat-and-Extend Regimen.

BACKGROUND AND OBJECTIVE: To evaluate the effectiveness and safety of low-energy stereotactic radiotherapy (SRT) combined with anti-vascular endothelial growth factor (VEGF) treatment following a treat-and-extend regimen (TER) in wet age-related macular degeneration (AMD). PATIENTS AND METHODS: Before/after SRT, the authors compared retrospective consecutive case series of 50 patients requiring frequent anti-VEGF treatment (every 4 or 6 weeks) in wet AMD, treated with a single session of SRT and TER (same manner pre/post-SRT). Outcomes were visual acuity (VA), recurrence-free interval, and central retinal thickness (CRT). RESULTS: After SRT, CRT was reduced from baseline (407.3 µm ± 153.2 µm) to 12 months (320.2 µm ± 112.1 µm; P < .001), with statistical significance from month 2 onward. VA was stable for 12 months (64.0 letters ± 15.1 letters vs. 63.6 letters ± 16.2 letters). The mean recurrence-free interval increased from 4.24 weeks ± 0.66 weeks to 7.52 weeks ± 3.05 weeks at 12 months (P < .001). No severe side effects were observed. CONCLUSION: Low-energy SRT, combined with anti-VEGF TER, was associated with reduced injection frequency and preserved VA during 12 months of follow-up. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:86-93.].

Septin expression in proliferative retinal membranes.

We undertook this study to evaluate the expression of septin family members SEPT5, SEPT8, and SEPT11 in proliferative retinal membranes. Epiretinal membranes (ERM) were obtained from seven patients with proliferative vitreoretinopathy (PVR) and from four patients and four postmortem eyes with proliferative diabetic retinopathy (PDR). Subretinal membranes (SRM) were obtained from one patient and six postmortem eyes. Membranes were examined by immunohistochemical staining of paraffin sections using polyclonal antibodies against SEPT5, SEPT8, and SEPT11 and an ABC detection system. SEPT8 expression was detected in all ERM and SRM, with an exceptionally strong expression of 100% for ERM of PVR, 63% for PDR membranes, and 57% for SRM. SEPT11 was identified in 91% of all cases, with strong expression of 14%, 25%, and 14% in ERM of PVR, PDR, and SRM, respectively. SEPT5 was seen in 54% of all cases; strong immunostaining was found in only one case of PVR membranes. Our finding suggests a role for members of the septin family in the development of proliferative retinal membranes.

Treat and Extend versus Pro Re Nata regimens of ranibizumab in neovascular age-related macular degeneration: a comparative 12 Month study.

PURPOSE: To compare outcomes in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) receiving ranibizumab treat and extend (TE) with those receiving ranibizumab pro re nata (PRN) in a clinical setting. METHODS: During this 12-month retrospective, consecutive, comparative case series, patients received ranibizumab 0.5 mg according to a TE or PRN regimen. Monthly optical coherence tomography (OCT) evaluation was performed during the PRN regimen; retreatment criteria included recurrence of intra-/subretinal fluid, or haemorrhages. During the TE regimen, initial treatment with 4-week intervals was sequentially lengthened by 2 weeks until signs of choroidal neovascularization (CNV) activity recurred. Study end-points included mean change in best corrected visual acuity (BCVA) and central retinal thickness (CRT), mean injection frequency and number of follow-up visits attended. RESULTS: Baseline characteristics were similar between the TE (n = 70) and PRN (n = 70) groups. Mean change in BCVA from baseline to Month 12 was significantly greater in the TE group than the PRN group (+0.18 ± 0.17 versus +0.07 ± 0.20, p < 0.001). Mean change in CRT from baseline to Month 12 was greater in the TE group than the PRN group (-116 ± 132 versus -58 ± 157 µm, p = 0.019). The number of follow-up visits attended was significantly higher in the PRN group than the TE group (11.9 ± 1.1 versus 8.6 ± 1.9, p < 0.001), while patients in the TE group received more injections during the study than those in the PRN group (8.6 ± 1.9 versus 6.0 ± 1.9, p < 0.001). CONCLUSION: Ranibizumab administered using a TE regimen in treatment-naïve patients with nAMD provided better visual outcomes with fewer clinic visits, compared with a PRN regimen.

Considerations for management of patients with diabetic macular edema: Optimizing treatment outcomes and minimizing safety concerns through interdisciplinary collaboration.

Diabetes is a growing worldwide epidemic and a leading cause of blindness in working-age people around the world. Diabetic retinopathy (DR) and diabetic macular edema (DME) are common causes of visual impairment in people with diabetes and often indicate the presence of diabetes-associated preclinical micro- and macrovascular complications. As such, patients with DR and DME often display complex, highly comorbid profiles. Several treatments are currently available for the treatment of DME, including anti-vascular endothelial growth factor (VEGF) agents, which are administered via intravitreal injection. While the safety profiles of approved ocular anti-VEGF therapies have been reassuring, the high-risk nature of the DME patient population means that treatment must be carefully considered and a holistic approach to disease management should be taken. This requires multidisciplinary, collaborative care involving all relevant specialties to ensure that patients not only receive prompt treatment for DME but also appropriate consideration is taken of any systemic comorbidities to evaluate and minimize potentially serious safety issues.

Comparing ranibizumab monotherapy and combination with single photodynamic therapy in wet AMD: retreatment and morphologic results.

PURPOSE: To evaluate retreatment indications/morphologic responses to ranibizumab monotherapy and combination with verteporfin photodynamic therapy (PDT). METHODS: A total of 40 patients received 3 monthly intravitreal ranibizumab 0.3 mg injections combined with either PDT or sham PDT at baseline (1:1) followed by as-needed ranibizumab based on predetermined vision/anatomical criteria. RESULTS: Retreatment criteria were visual acuity (VA) loss (59%/58%), central retinal thickness (CRT) increase (27%/26%), or both (14%/16%). One month before retreatment, intraretinal cysts (IRC) were present in 84%/74%, subretinal fluid (SRF) in 70%/63%, and at least one of them in 84%/89% of eyes. A significant decrease in mean leakage area, IRC, and SRF as well as a reduction in presence of hemorrhages and hard exudates occurred in both treatment groups at 12 months (compared to baseline). CONCLUSIONS: Retreatment indications were mostly based on VA loss, probably due to the quantitative optical coherence tomography criterion. Intraretinal cysts and SRF were earlier predictors for recurring choroidal neovascularization (CNV) activity than CRT/VA changes. Both treatment strategies were equally potent in reducing CNV activity.